Apotex Quality Assurance Officer Vacancy – Apply Online
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.
Job Title: Sr Officer, Quality Assurance-ARPL-BCA AR
Location: Bangalore, KA, IN, 560099
- M. Sc., /M. Pharm., /B. Pharm.
- 2-3 years of auditing experience in the pharmaceutical industry.
Experience in GLP/ GCP along with a strong understanding of compliance in these areas.
- 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;
- Bioanalytical 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 Bioanalytical 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 complete 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.
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