Opening for the post of Regulatory Affairs Officer @ Quintiles

Opening for the post of Regulatory Affairs Officer @ 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.

Post: Reg Affairs Officer 1-1501974

Job Description:
1. Primary Masters degree in Pharmacy, biotechnology, chemistry or life science. 
2. 3-5 years CMC regulatory affairs experience with in-depth knowledge and experience of regulations and requirements for Life Cycle Management of various types of products (variations, labeling updates, MA transfers, Module 3 prepration, SmPC, renewals)
3. Demonstrated strong writing and communication Skills
4. Strong attention to detail, ability to multi-task

• Liaises with internal (onsite and global) or client staff to obtain documents for use in authoring global post-approval CMC submissions and LCM activities
• Plans and authors regulatory submissions using a client template, Quintiles templates, or using the clients IT systems/platform
• Submissions include: Module 3, Module 2.3, variations, new BLAs for EU, US & ROW markets
• Attends internal meetings as necessary to support submission authoring projects
• Serve on global projects supporting clients in drug development and discovery for various therapeutic areas

Candidate Profile
Bachelors Degree, with 4 yrs relevant exp in Regulatory.

Additional Information:
Experience: 4 year
Location: India
Job Id: 1501974
Last Date: 25th June, 2015

Click here to apply

Opening for Trainee Clinical Research Associate @ Novo Nordisk

Opening for Trainee Clinical Research Associate @ Novo Nordisk

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post: Trainee Clinical Research Associate

Novo Nordisk is looking for an Trainee Clinical Research Associate, who would ensure smooth conduct of all clinical trials sponsored by NNIPL in accordance with good clinical research practice guidelines by NN A/S and local regulatory requirements.

Job Description
The key responsibilities Trainee Clinical Research Associate is to learn through induction and on the job training about various trial related activities. Become thorough in ICH-GCP guidelines, Novo Nordisk SOPs, trial and processes & local regulatory requirements.
To assist CRA/LTM in the conduct of site initiation visits as per agreed timelines and prepare initiation report as per timelines.
To gain monitoring experience through co-monitoring visits and on-job trainings.
Last but not least, acting in line with ethical standards of the organization by personally observing when in the field that we all live with BE policies.

Qualifications
You hold Graduate/Post graduate in science, Pharmacy or Medical. Additional qualification in clinical research would be preferred. Minimum 1 year experience trainee CRA or 1-2 years of experience in clinical research in a CRO or a Pharma company.
You have excellent communication & influencing skills and can drive projects and processes.
You are fluent in both written and spoken English.

Additional Information:
Experience: 1-2 Years
Qualification: Graduate/Post graduate in science, Pharmacy or Medical
Location: Bangalore- Karnataka
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Requisition ID 29677BR
Last date: 25th June, 2015Click here to apply

Short motivational story - How to reach solutions to our problems?

A father left 17 camels as an asset for his three sons.

When the father passed away, his sons opened up the will. The Will of the father stated that the eldest son should get half of 17 camels while the middle son should be given 1/3rd (one-third).The youngest son should be given 1/9th (one-ninth) of the 17 camels.

As it is not possible to divide 17 into half or 17 by 3 or 17 by 9, three sons started to fight with each other.

So, the three sons decided to go to a wise man.

The wise man listened patiently about the Will. The wise man, after giving this thought, brought one camel of his own and added the same to 17. That increased the total to 18 camels.

Now, he started reading the deceased father’s will. Half of 18 = 9. So he gave the eldest son 9 camels 1/3rd of 18 = 6. So he gave the middle son 6 camels 1/9th of 18 = 2. So he gave the youngest son 2 camels.

Now add this up: 9 plus 6 plus 2 is 17 and this leaves one camel, which the wise man took back.

Moral :The attitude of negotiation and problem solving is to find the 18th camel i.e. the common ground. Once a person is able to find the common ground, the issue is resolved. It is difficult at times. However, to reach a solution, the first step is to believe that there is a solution. If we think that there is no solution, we won’t be able to reach any!

Opportunity to work as 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: 10^th June, 2015

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Opening for Senior Scientist, Research Associate- DMPK @ Hetero

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs.

Post: Senior Scientist, Research Associate

Senior Scientist (DMPK)
M.Sc/M.Pharmacy with 6-8 years of relevant experience or Ph.D with 2-3 years of experience or Ph.D with 2-3 years of experience in in vitro & in vivo DMPK assay establishment & NCE screening. Hands-on experience with LC/MS & in conducting studies with rodents & non rodents. Preferably pharmaceutical discovery research experience.

Research Associate (DMPK)
M.Sc/M.Pharmacy with 3-5 years of relevant experience in conducting in vitro and in vivo DMPK expenments. Preferably pharmaceutical discovery research experience.

Interested candidates can send their profiles toramreddy.d@heterodrugs.com

Vacancy for B.Pharm/ D.Pharm as Research Assistant @ AIIMS, Rishikesh

AIIMS, Rishikesh is one of the SIX AIIMS like apex healthcare institutes being established by the Ministry of Health & Family Welfare, Government of India under the Pradhan Mantri Swasthya Suraksha Yojna (PMSSY). With the aim of correcting regional imbalances in quality tertiary level healthcare in the country, and attaining self sufficiency in graduate and postgraduate medical education and training the PMSSY planned to set up 6 new AIIMS like institutions in under served areas of the country.

A Research Assistant is required for the intramural project entitled “Knowledge Attitude and Disposal practices among drug stores in North India” at Department of Pharmacology, AIIMS, Rishikesh.

Post: Research Assistant

Qualification: B.Pharm/ D.Pharm from a recognized college

Experience: Experience in research work previously with excellent communication skills will be preferable

Age: Not more than 25 years

Job Profile: This is a temporary job and will require survey of drug stores in and around Dehradun and Rishikesh. It will involve local travel for at least 20 days in a month.

Duration: The duration of joining is for 3 months only.

Remuneration: Rs. 10,000 per month will be paid as salary for the duration of project. Travelling Allowance @ Rs 200 per visit will be paid additionally as per government rules.

Last date of application: 10/06/2015 (5 PM)

Apply either by post to: Dr. Puneet Dhamija, Department of Pharmacology, 3rd Floor, A-6 Block, AIIMS, Rishikesh, Uttarakhand

or through email (signed and scanned forms only):pharmacologyaiimsrishikesh@rediffmail.com

Shortlisted candidates will be called for interview at their own cost at AIIMS, Rishikesh

Selection of the candidate will be through project selection committee and its decision will be final.

Note: This post is purely on contract basis and will not be extended beyond the project’s time period. It is not an employment with AIIMS, Rishikesh.

Employment will be based on satisfactory work performance of the Research Assistant and will be terminated with immediate effect if the performance is not found satisfactory.

CANDIDATES WHO HAVE APPLIED PREVIOUSLY SHOULD APPLY AGAIN USING THE REVISED FORMAT

FOR MORE INFO

Opening for Life science/ Chemistry/ Pharma Graduates & Post-Graduates @ Sun Pharma

Opening for  Life science/ Chemistry/ Pharma Graduates & Post-Graduates @ Sun Pharma


Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story.

Job Title : Officer / Sr. Officer - Central Analytical Laboratory

Eligibility : M.sc Life science/ Chemistry/ B.pharma/ M. pharma

Experience : 2-5 years

Job Description :

    To design the protocol of Method Validation
    To design the experiments of validation of APIs and Formulations.

    To perform the degradation study of API and Formulation
    To design the mass balance of degradation compounds
    To perform the identification of degradation compounds by LCMS/GCMS
    To prepare the validation reports as per GLP norms
Click here to apply

Opening for Life science/ Chemistry/ Pharma Graduates & Post-Graduates @ Sun Pharma

Opening for  Life science/ Chemistry/ Pharma Graduates & Post-Graduates @ Sun Pharma


Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story.

Job Title : Officer / Sr. Officer - Central Analytical Laboratory

Eligibility : M.sc Life science/ Chemistry/ B.pharma/ M. pharma

Experience : 2-5 years

Job Description :

    To design the protocol of Method Validation
    To design the experiments of validation of APIs and Formulations.

    To perform the degradation study of API and Formulation
    To design the mass balance of degradation compounds
    To perform the identification of degradation compounds by LCMS/GCMS
    To prepare the validation reports as per GLP norms
Click here to apply

Openings for M.sc Life science / Pharma Candidates as for Executive-QA Posts @ Himalayas

Openings for M.sc Life science / Pharma Candidates as for Executive-QA Posts @ Himalayas

Working in Himalayas means to learn and grow continuously.Opportunities to work on the finest ever products in the herbal space, competitive salaries and excellent benefits. We offer challenging assignments, a world class working environment, professional management and ample prospects to train and learn along with exceptional rewards.

Job Title: Executive - Quality Assurance (analytical)

Qualification: M.sc Life science, B.pharma/ M.pharma

No of Openings : 3

Experience: 1-3 years

Job Description:

Review of Specifications and Test Methods
Review of Analytical Method Validations, Method Transfers
Review of Stability protocols and reports
Review of OOS, OOT and other lab investigations.
Conducting QC Audits
Ensuring GLP

Click here to apply

Opening for Ph.D Life science Freshers in Formulation & Development @ Cipla

Opening for Ph.D Life science Freshers in Formulation & Development @ Cipla

Cipla is one of the most respected pharmaceutical companies not just in India but across more than 170 countries. Our portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally. Cipla's turnover in FY13 was 1.5 billion USD.Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support.Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients.

Job Title : Formulation & Development (PhD Candidates)

Eligibility : Ph.D Life science

Experience : 0 years

No of Openings : 2

Job description :

    Capable of handing formulation development of sterile formulation and also technology transfer to the manufacturing plant.
    Understanding of USFDA, EU Etc , regulatory guidelines, ICH, PDA Requirements, scaling up, manufacturing aspects of sterile dosage forms (Solution, suspensions, emulsions
    Require only PhD Freshers
Click here to apply

Openings for Scientist I Molecular Biology @ ThermoFisher Scientific

Openings for Scientist I Molecular Biology @ ThermoFisher Scientific

We’re a global biotechnology company dedicated to improving the human condition. Our industry-leading brands are found in nearly every life sciences lab in the world, including innovative instrument systems under the Applied Biosystems and Ion Torrent names. We’re also responsible for a broad range of reagents with our Invitrogen, GIBCO, Ambion, Molecular Probes and Taqman products. With approximately 3,900 patents and exclusive licenses, we’re home to one of the largest intellectual property estates in the life sciences industry

Post: Scientist I Molecular Biology

Job Description
Experience/Requirements:
Requires a minimum of 3 year laboratory experience in a working environment.
Demonstrated ability to carry out scientific procedures and make recommendations for improvement required.
Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials relating to one or more of the following: protein purification, tissue culture, protein expression in bacterial and mammalian cell culture systems, and protein analysis strongly preferred.
Good problem solving skills necessary

Responsibilities:

    Use of laboratory skills to complete production and QC of biochemical assay, cell based with the production schedule and processes, with an advanced understanding of related technical processes.
    Responsible for recording and documenting detailed observations during production work in batch records, notebooks, reports and work order documents following good documentation practices.
    Able to analyze the data to ensure production/QC is within expected operating parameters, and where needed, design troubleshooting experiments to identify and solve technical production/QC.
    Responsible for conducting maintenance and support of all laboratory equipment and components such as detection or automation instruments.
    Contribute ideas and lead projects and/or teams aimed at improving and optimizing exist standard laboratory techniques, processes, protocols and equipment.
    Drive productivity improvements and efficiencies in the laboratory environment to deliver cost savings in the manufacturing department.
    Responsible for training peers and offering technical guidance to team members
    Responsible for updating product protocols and processes change.
    Respond quickly to changing priorities and handle multiple projects at once, with overlapping deadlines.
    Responsible for maintaining, tracking and ordering supplies to ensure reagents are available to complete projects with a rapid turnaround. Interact with supply chain members to ensure quality of raw materials received.
    Responsible for ERP data management, reports and display strong interpersonal skills in working with team members.
    Comply with all company safety regulations and procedures.
    Comply with the company’s commitment to quality by documenting and advising team members of factors that may impact product quality.
    May be required to perform other related duties as required and/or assigned

Minimum Qualifications (must have)
Proficiency in molecular bacterial cloning. DNA isolation, bacterial transformation and good understanding of recombinant cloning technology.
M.S. with one year or B.S. with four year experience in molecular biology or biotechnology.

Additional Information:
Experience: 4 Year
Qualification: M.Sc. or M.Tech. Degree
Requisition ID: 20447BR
Industry Type: Pharma/ Biotech/Clinical Research
Location: Bangalore
End Date: 25st June, 2015

Click here to apply

Opportunity to work as a Consultant @ PAREXEL

Opportunity to work as a Consultant @ PAREXEL

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.

Post: Consultant

Job Description:
The Consultant role involves management of strategic projects per client expectations in addition to maintaining/strengthening existing client relationships

Key Accountabilities
• To successfully contribute towards the global consulting business via successful management of strategic projects in line with deliverables and client expectations
• To utilise your industry insight and practice in the development of convincing deliverables and recommendations, gaining the successful buy-in of clients
• To provide a high level of relationship management and liaison with existing clients, instilling confidence with your abilities and expertise within the field
• To assist clients with the development of product value propositions, investigations and market understanding related to views and opinions of payers, health policy makers and price sensitive customers
• Lead by example on aspects of client presentation and project delivery
• Feed ideas for, and support, process improvement into the organisation

Skills
• Excellent interpersonal, verbal and written communication skills
• Proven client interaction/relationship skills
• A flexible attitude with respect to work assignments and new learning
• Demonstrable experience of acting as an innovative and strategic problem solver
• Knowledge and experience of developing systems, processes, measurement systems, quality standards
• Hands on knowledge of computers especially Microsoft Excel & Microsoft Word

Candidate Profile
More than five years
Education
• Recognized Post graduate or PhD degree in Pharmacy/ life sciences
Language Skills
• Good verbal and written English Communication skills

Minimum Work Experience
• 4-6 years’ experience with a Pharma- KPO/ Pharmaceutical company

Additional Information:
Experience: 4-6 years
Education: Post graduate or PhD degree in Pharmacy/ life sciences
Location: Chandigarh
Functional Area: Other
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
pare: 10042977
End Date: 30th June, 2015

Click here to apply