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.
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