Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
Post : Sr Officer, Quality Assurance - ARPL-BCA AR
Job Description
• Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable.
• Performs 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.
• Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the Bio analytical Operations/Clinical Operations/others Department as applicable.
• Prepares QA audit reports for all the above audits/surveillances performed.
• Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
• Performs audit / review of software validation packages and IQ/OQ documents for systems used within the facility.
• Assists in the formal training of new and existing QA staff members to both QA and facility audit and procedures.
• Revise, implements, and maintains records of standards Operating procedures and additional relevant documents for the facility.
• Assists in System Audits whenever required.
• Reports to Team Leader/Group Leader/Deputy Manager/Manager 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 ValuesDemonstrates 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.
Candidate Profile
• M. Sc / M. Pharm., / B.Pharm.
• 2-3 years of auditing experience in the pharmaceutical industry.
• Experience in GLP/ GCP along with strong understanding of compliance in these areas.
Additional Information
Experience : 2-3 years
Qualification : M.Sc / M.Pharm., / B.Pharm
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality Assurance-ARPL-BCA AR
End Date : 30th October, 2021
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