Work as Manager of Clinical Data Management @ PPD Pharmaceuticals

Work as Manager of Clinical Data Management @ PPD Pharmaceuticals

PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.

Post: Manager of Clinical Data Management_ Bangalore - 124160

Job Description
The Manager of Clinical Data Management will manage day-to-day operations for a group of CDM projects or key functions as well as manage the project staff and workloads for direct reports. A CDM Manager will be responsible for customer contact, functional, administrative and financial oversight of projects assigned. They will participate in the development and implementation of processes, procedures and training for the data management function. The CDM Manager will provide supervisory functions for individual contributing staff within the CDM department including training and mentoring of staff. Managers may be expected to participate in business development activities.

- To provide supervisory functions for a team of allocated staff within the CDM department including training and mentoring.
- To support HR and CDM management with the hiring, discipline and discharge of staff as necessary.
- To perform performance appraisal and ongoing staff development for direct reports.
- To supervise the data management set-up activities for each assigned project.
- To ensure that all data management activities are conducted in line with regulatory guidelines, SOPs, and client expectations, ensuring that projects are completed on time, accurately and within budget.
- Provide regular and timely communication with colleagues in other functional groups.
- To provide accurate project metrics and resource information at the request of CDM management, and to effectively use this information to manage progress of assigned projects.
- To allocate clear responsibilities within the data management study team for each assigned project to enable all targets to be met. Delegate tasks to team members as appropriate, providing guidance and support as necessary.
- Manage project forecasting of hours and identify resource requirements.
- To identify potential out of scope activities to Project Managers and CDM management and assist with the contract modification process.
- Participate in the development and implementation of processes, procedures and training for the data management function as directed.
- To participate in business development activities, assisting with bid preparation and by representing data management at bid defense meetings. Additionally, promote repeat business by developing relationships with existing sponsors.

Candidate Profile
A Bachelor's degree OR certification in a related allied health profession from an appropriately Accredited institution (i.e. RN, MT, PA, RPh, RT) is necessary to perform the job. The candidate
should also come with at least 5 years of data management and acted as a team lead on a multi-person team, not necessarily in data management.

Additional Information:
Experience: Min. 5 Years
Location: Karnataka-Bengalaru
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
Job Code: 124160
End Date: 15th July, 2015

Click here to apply

opening forbTrainee Auditor (clinical QA) @ Apotex Research Pvt. Ltd.

opening forbTrainee Auditor (clinical QA) @ Apotex Research Pvt. Ltd.

Job Description
Assists auditors, senior auditors, Team Leaders and Group Leaders in Ensuring that the assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Performing audits (both project and non-project related) to assure the compliance to GCP/ GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical Operations, Clinical Operations Department, Pharmacokinetic Unit, Quality Assurance Unit, and Other general divisional operations.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Conducting in-process surveillance (both project and non-project related) to assure compliance of the Bio analytical Operations/ Clinical Operations Department/ others as applicable.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Preparation of QA audit reports for all the above audits/surveillances performed.
Assists auditors, senior auditors, Team Leaders and Group Leaders in Conducting appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
Assist to auditors & senior members in performing audit / Review of software validation packages and IQ/OQ documents for systems used within the facility.
Reports to Team Leader/Group Leader/Deputy Manager/Senior Manager R & D Quality with respect to the operational status and disposition of all matters relating to the operations in the QA unit.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned.

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:Medical Professional

Role:Clinical Researcher

Keyskills
BA BE Studies Pharmokinetics Clinical Research Clinical Monitoring Clinical QA Quality Assurance Clinical Quality Assurance QA BA Studies BE Studies
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Doctorate Not Required
0-1 years of auditing experience in the pharmaceutical industry.
Experience in GLP/ GCP along with strong understanding of compliance in these areas.
M Pharma - Pharmacology only
Language proficiency - Hindi is a must
Company Profile:
Apotex Research Pvt. Ltd.
Apotex Inc., founded in 1974, is the largest Canadian-owned pharmaceutical company. We employ over 6,000 people worldwide in research, development, manufacturing and distribution. We produce more than 300 generic pharmaceuticals in approximately 4000 dosages and formats and export to over 115 countries around the globe.

APOTEX RESEARCH PRIVATE LIMITED (ARPL) based at Bangalore is a 100% owned subsidiary of Apotex Inc., and is engaged in the development, bio-clinical evaluation, manufacturing and distribution of safe and efficacious generic pharmaceutical formulations for the global market.

As a part of this dynamic team, you will get to work in our state-of-the-art facilities, which include sophisticated equipments', high standard processes and the opportunity to work alongside some of the world's top professionals.

Apotex encourages the new technological developments in the field of research, manufaturing and distribution and embraces all the new techniques and technologies available in our area of concentration, our new manufaturing facility has been inaugurated in June 2012 and uses some of the most sophisticated technologies and machines available today.



Click here to apply

Opening for Scientific and Medical Writer in Crest

Established in 2006, Crest is an IT and ITES company that offers services in premedia, data conversion, software development, research & analysis and marketing & BPO. We are a Springer group company with invaluable insight into European and American markets and the advantage of being based in India. We have perfected our offshore delivery system, working with some of the world’s largest STM publishers.

Post: Scientific and Medical Writer

Job Description
- Required background and experience: you will have working experience in the pharmacovigilance/drug Identifying and evaluating individual case safety reports (ICSRs) of adverse drug reactions from the published literature
- Creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing ) to support the drug safety reporting and information requirements of Pharma industry clients
- Safety field and a background in medicine or pharmacy
- Ideal experience would include:
- Scanning the literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
- Detailed evaluation of individual case reports e.g. determining seriousness of adverse events, determination of drug causality, subsuming signs and symptoms into clinical diagnoses etc.
- Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authority.

Candidate Profile
- Minimum 1+ years of experience in Pharmacovigilance
- Scanning scientific literature or other data sources to identify reportable adverse drug reactions based on accepted industry and regulatory guidelines
- Familiarity with the reporting and regulatory requirements for pharmaceutical companies as mandated by drug safety authorities
- Knowledge of global pharmacological regulations
- Excellent command over English language (written and verbal)
- Decent knowledge of ICH guidelines and regulations relating to safety reporting

Interview Process
- Screening – Candidates appear for Language and Technical tests
- First round – Telephonic/Personal Interview with Team Lead includes Technical questions and topics and assessing your skills for the position
- Second round – Skype/Personal Interview with Sr. manager to determine your  suitability for a particular group within the division you have applied to
- HR round – Discussing Company policies and salary expectations.  If you are successful in the interviews an offer is rolled out along with compensation structure and other rules related to employment

Additional Information:
Experience: 1+ years
Categories: Research & Analysis
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 25^th July, 2015

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Required for Manager, Quality Assurance in Nektar

Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient.

Post: Manager, Quality Assurance (India)

Position Summary
Manage Development, implementation and maintenance of Quality Systems and related activities. Manage activities for generation and review of Quality System Documentation used particularly in Good Manufacturing Practices (GMP) including ICH analytical and stability requirements and on need basis according to Good Laboratory Practices (FDA and OECD principles). Management of schedule for internal audits, client (CRO or CMO) and external audits. Manage audits and reporting of in house studies in support to development programs in a timely manner. Participate in program team meetings, and assist in preparing documents for regulatory filings. Coordinates inter-site location activities.  Assist in resolving GxPs compliance related issues and improve efficiency. Assisting in selection, development, and evaluate personnel to ensure the efficient operation of the function. Contributes to and supports the company’s development programs. Leads direct report staff.

Responsibilities
Responsible for implementing and monitoring compliance to cGMP regulations. Evaluation of vendors including contract research organizations for regulatory compliance before contracting studies.  Review, compile, approve, control and distribute master schedules, SOPs and other quality documents. Review and release drug substance and drug product data packages for regulatory filings. Conduct study audit, review work plans, and test procedures, including verification of successful close out.  Review of deviations, changes and corrective and preventive actions program.  Review of validations and qualification documents. Over all supervision of archives and related activities and document control.  Coordinate and participate in internal Quality audits and follow-up audits.  Will provide assistance during inspections by regulatory agencies.  Effectively manage and motivate direct report staff- Interacts with internal and external stakeholders on quality matters.

Requirements
Masters degree in Biology, Chemistry or Pharmacy. Experience of 8-10 years working in Quality environment with a thorough understanding of GxPs (cGMP) is essential. Understanding on GLPs (FDA, OECD) would be added advantage. 3-5 years managerial experience is desirable. Comprehensive knowledge of GxPs with emphasis on ICH analytical and stability requirements for drug substance and drug product; and ability to correctly interpret regulatory guidelines/standards is a must (US FDA 21 CFR Part 210, 211, 58 and OECD). Experience with documentation systems and with document review and auditing skill. Working knowledge in quality sciences, statistics, and computer-based operations is required.  Verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Experience working in a team-focused environment is preferred.  Must be detail oriented.

Additional Information:
Experience: 8-10 years
Education: Masters degree in Biology, Chemistry or Pharmacy
Location: Hyderabad
Job ID: IN2894-3460-2015
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 28^th February, 2015

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Senior Clinical Process Specialist @ Quintiles

Senior Clinical Process Specialist @ Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: Sr. Clinical Process Specialist-1512201

Job Description:
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• May provide assistance to the CTL with design of study tools, documents and processes.

Candidate Profile:
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- In depth therapeutic and protocol knowledge as provided in company training
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
- Strong written and verbal communication skills including good command of English language
- Excellent organizational and problem-solving skills
- Strong time management skills
- Ability to manage competing priorities
- Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in a health care or other scientific discipline or educational equivalent and 3 years of on-site monitoring experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Frequent travel to sites, primarily domestic, may include international travel

Additional Information:
Experience: Min. 3 years
Location: Bangalore- Karnataka
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Last Date: 25th July, 2015

Click here to apply

Opportunity for Executive - Production @ Johnson & Johnson

Opportunity for Executive - Production @ Johnson & Johnson

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Post: Executive - Production-1500038613W

Job Description
Summary of the position:  To participate in development and setting  of the production systems in new plant during project phase and ensure Manufacturing of products in the shifts are in accordance with J&J Specifications while meeting GMP & HSE requirements during the commercial phase

Project Responsibilities:
- Creation of the SOP’s & Work Instructions for manufacturing & fill/pack.
- Development and training of the production associates
- Participate in  Manufacturing systems Validations (Equipment & Process) & Support Q&C/Technical Assurance/Engineering  in handling of Quality Systems
- Lead from front to ensure safe behavior /GMP culture on the shop floor during plant commissioning
- Work with cross-functional team to meet the project goals and objectives

General Responsibilities:
- Manpower planning & allocation of people on the manufacturing lines during the shifts
- Documentation control– Batch record Sheets, production log books, other documents required to meet GMP & HSE requirements
- Meeting the production targets & delivering the target OEE’s
- Maintain & perform Good Manufacturing Practices on the shop floor
- Perform the SAP transactions for accounting of material & FG’s
- Coordinate raw & packing material planning with the warehouse
- Support new products development, trials, validation & CIP projects
- Control material wastage & meet the expected yields
- Develop/train operators & support to maintain good Industrial relations with shop floor employees
- Implement Lean on the shop floor
- Regulatory Compliance, Planning, Coordinating and Controlling the Production process effectively with Safety, Quality & productivity in mind
- Quality Assurance through effective participation in development, implementation and monitoring the QA systems on shop floor

Candidate Profile
Education: BSC/MSC, B Pharm/M Pharm, Engg
Experience: 8 to 10 years relevant experience in Pharma or FMCG company with 2 to 3 year experience into man management.
Critical Skills (Certification/s): Competent Technical Staff for cosmetic & External preparations from FDA

Additional Information:
Experience: 8 to 10 years
Qualification: B.SC/M.SC, B.Pharm/M.Pharm, Engg
Location: Andhra Pradesh-Hyderabad
Functional Area: Production
Industry Type: Pharma/Biotech/Clinical Research
End Date: 25th July, 2015

Click here to apply

Opening for Bio-Chemistry/Chemistry/Microbiology Candidates in medical coding domain @ Dell

Opening for Bio-Chemistry/Chemistry/Microbiology Candidates in medical coding domain  @ Dell

Dell is a Technology driven company with a unique Dell Direct model. Dell Information Technology department (Dell I/T) plays a key role in enabling the Dell Direct model by creating, deploying and supporting global industry-leading I/T assets and services that reliably deliver the best customer experience and competitive edge.

Job Title : Medical Records Coder Associate.

Eligibility : B.tech/M.tech/ B.sc/M.sc, Bio-Chemistry,Chemistry, Microbiology

Experience : 2-4 years

Job Description :

    Codes and abstracts information from a variety of medical records and assigns appropriate codes based on medical documentation using CPT-4 and ICD-9/ICD-10 coding guidelines.
    Follows strict coding guidelines within established productivity and quality standards for all accounts assigned
    Strong knowledge in either one or more of the Coding Specialty: - Family Practice, Orthopedic, Pediatrics,Surgery, E&M, Cardiology, Anesthesia, ED.
    If information is insufficient in the reports to assign the most suitable codes, shall suggest/take next steps or escalate for proper documentation in order to enhance proper filing of reports.

    Develops expertise and knowledge in area of specialization and help mentoring relatively new team members
    Understands team objectives and service requirements
    Conduct quality check and provide feedback to team members.
    Responsible for attending trainings to enhance coding knowledge, skills, compliance awareness and maintenance of credentials
    Maintains patients' confidentiality and adhere to standard compliance and requirements
    Fair knowledge in Human anatomy and physiology
    Good understanding of healthcare practices
    Working knowledge of coding principles, governmental regulations, protocols and third party requirements regarding billing and billing documentation and application of specialized technical skills.
    Demonstrate knowledge of internal operations and develop relationships to facilitate workflow.
    Apply specialized knowledge to coordinate day-to-day work
    General understanding of business and business needs.

Qualification :

    Any life science graduates (BPT, nursing) or medical transcription preferred.(Non Life Science Graduates please excuse)
    Certification in Coding (CPC) preferred
    Two plus years of coding experience in either one or more specialty - Family Practice, Orthopedic, Pediatrics,Surgery, E&M, Cardiology, Anesthesia, ED.

Click here to apply

Lac Operon

The Lactose Operon
An operon is a cluster of bacterial genes along with an adjacent promoter that controls the transcription of those genes.

Walkin Interview for Clinical Record Management @ Quintiles

Walkin Interview for Clinical Record Management @ Quintiles

Job Description

We are conducting Walk-in event on Saturday, 27th of june for  Clinical Record Management/ document Management
Exp: 1-4yrs

Job Location :Bangalore
Date: June 27th , Registration Time : 8.00AM - 9.30AM
Venue: Quintiles,
Wing A, Etamin Block, Prestige Tech Park
Sarjapur - Marathalli , Outer Ring Road.
Bangalore: 560103
Land Mark : JP Morgan Stop

Contact Person : Shashikala

please find below the JD .

If available for the interview , please share updated CV with the following details.

Currentc CTC:
Expected CTC:
Notice Period:
Total Exp & Relevant Exp:


Job Title:  Clinical Record Management

1. Bachelor's/primary degree from life science ground .
2.Ggood knowledge in clinical research & clinical trial
3. Basic knowledge of applicable research and regulatory requirements, i.e.,ICH GCP and relevant local laws,regulations and guidelines.
4. Effective written and verbal communication skills including good command of English language.

Click here to apply

Walkin For Fresher Life Science/pharma - 29th June to 3rd July @ Quintiles

Walkin For Fresher Life Science/pharma - 29th June to 3rd July @ Quintiles

Job Description

We have opening for Fresher Life Science/Pharma -  Clinical Data Management.

Interested candidates can walkin between 29th June to 3rd July at the below mentioned venue:

Time : 9:30 AM
Venue:
Quintiles Technologies India Pvt. Ltd.
Prestige Technology Park II,
Etamin Block (Building B3), B wing, 1st floor
Sarjapur-Marathalli Outer Ring Road,
Bangalore - 560103

Contact : Rekha/Indrani

Click here to see more info

Vacancy as Project Research Scientist @ IRCC

Vacancy as Project Research Scientist @ IRCC

 
Applications are invited from the citizens of India for filling up the following temporary position for the sponsored project undertaken in the Department of Biosciences and Bioengineering of this Institute. The position is temporary initially for a period of 1 Year and tenable only for the duration of the project. The requisite qualification & experience etc. are given below:

Post: Project Research Scientist (1 Post)



Consolidated salary: Rs.42000 - 60000/- p.m.

Project Code, Project Title & Funding Agency
15GATES001: "Postdoctoral position for candidates with PhD in Biosciences, Pharmacy, Nanotechnology or relevant areas with excellent academic record. Strong Publication record a must. Candidate should have experience in either nanoparticle development or transdermal delivery systems. " (BILL AND MELINDA GATES FOUNDATION.)



Qualification: Postdoctoral position for candidates with PhD in Biosciences, Pharmacy, Nanotechnology or relevant areas with excellent academic record. Strong Publication record a must. Candidate should have experience in either nanoparticle development or transdermal delivery systems.

Job Profile: Develop and characterise nanoparticles and transdermal patches for drug delivery

The appointment is for time bound project and the candidate is required to work mainly for the successful completion of the project . The selection committee may offer lower or higher designation and lower or higher salary depending upon the experience and performance of the candidate in the interview.
Candidate possessing the requisite qualification and experience should apply online at http://www.ircc.iitb.ac.in/IRCC-Webpage/rnd/HRMSLoginPage.jsp , if there is any problem applying online, candidates may apply on plain paper stating the CIRCULAR NO. No. , project title, position applied for, name, permanent and mailing addresses, date of birth, details of academic qualification and experience or download the Application form available on http://www.ircc.iitb.ac.in/IRCC-Webpage/rnd/ProjectStaffInfo.jsp with the copies of certificates/testimonials and must super scribe the envelope with CIRCULAR NO. No. _____  & POST: _____ to the Asstt. Registrar (R&D), Indian Institute of Technology, Bombay, Powai, Mumbai-400076 so as to reach on or before 3rd July, 2015. Candidates called for interview will be required to attend at their own expenses.

INDUSTRIAL RESEARCH & CONSULTANCY CENTRE
OFFICE OF THE DEAN(R&D)
INDIAN INSTITUTE OF TECHNOLOGY,BOMBAY.

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Opening for the post of Field Content Executive @ Healthkart.com

Opening for the post of Field Content Executive @ Healthkart.com


We are using this platform to build a vast and meaningful network for the health needs we have every day. When we grow up, we want to be the country's premier health network.
Since 2011, we have grown to become the destination online for health supplements, health, fitness and wellness products, elderly care and diabetes products, and sexual care accessories.

Post: Field Content Executive



Job Description
Responsibilities:
-Work on the verification work stream which includes calling doctors/clinics, getting the necessary information and entering it into the database.
-To seek awareness about the Company’s and Product’s vision, goals and plans.
-Send daily reports with progress and action to your team leader.
-Take appointments and visit clinics/doctors to collect detailed information of the doctor and clinic.
-Ensure information collected is of high quality and collected information is uploaded everyday into the system.
-To be a good team player and contribute towards maintaining high levels of motivation across the team - with positivity in thoughts, words and action – particularly during team meetings.
-To constantly chase and exceed the efficiency benchmarks in terms of:
i. Average number of meetings per day
ii. Daily and Monthly Target achievement

Basic Requirement:
Should have own Laptop or Smart phones;
Should know basic knowledge about MS Office and MS Excel .
Good Communication skills;



Candidate Profile
Graduate + Under Graduate,
1 year + exp.
Freshers can also apply.

Additional Information:
Education:  Any
Location: Mumbai
Functional Area: Other
Industry: other
Last Date: 25th July, 2015

Interested candidates can send their CV at anant.agrawal@1mg.com