Executive – Annual Product Quality Reviews at Apotex, Mumbai
A unique opportunity has emerged at Apotex for the position of Executive – Annual Product Quality Reviews in Mumbai. This Apotex jobs Mumbai opportunity is ideal for candidates with 3-6 years of experience in pharmaceutical Quality Assurance, particularly in APQR compilation and GMP compliance.
About Apotex
Apotex is a Canadian-based global health company recognized for its extensive portfolio of generic, biosimilar, and innovative branded pharmaceuticals, as well as consumer health products. With regional offices in the United States, Mexico, and India, Apotex is committed to improving access to high-quality medicines for patients around the world.
Company: Apotex
Position: Executive – Annual Product Quality Reviews
Department: Quality Assurance
Location: Mumbai, MH, IN, 400079
Qualification: M.Sc, MBA, B. Pharm, M. Pharm
Experience: 3-6 Years
Work Mode: On-site
Application Mode: Online
Apotex Jobs Mumbai: Job Description
The selected candidate will be responsible for compiling annual product quality reviews (APQRs) in accordance with applicable SOPs. This role involves collecting, analyzing, and summarizing product review data accurately and within required timelines. A strong understanding of regulatory expectations and documentation discipline is essential, along with the ability to work with analytical data from LIMS or other acceptable systems. Candidates exploring Apotex jobs Mumbai should have the stated QA and data-review capabilities.
Key Responsibilities
- Perform Annual Product Quality Reviews (APQRs) compilation as assigned, as per SOP.
- Compile APQR sections including Manufacturing Process Overview, Batches Released/Rejected, APIs, Excipients, Changes, Test Method, and Specification.
- Review Manufacturing/Process Validation, Equipment and Utilities Qualification, and Sterility Validation/Qualification, if applicable.
- Include Packaging Component Deviations/Changes, Compendial Review, Deviations, Critical In-Process Attributes, and Analytical Test Results in APQR compilation.
- Cover Recalls and Field Alerts, Returns, Retention Samples Review, Technical Agreements, Marketing Authorizations Variations, Post Market Commitments, Complaints, Stability, Conclusion, and Product Rating, and Concerns, Recommendations, and Issues for Follow-Up as applicable.
- Perform complete and correct transactions of data as per SOP/WI’s.
- Summarize and trend analytical data from LIMS or other acceptable systems.
- Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
Eligibility Criteria
- M.Sc, MBA, B. Pharm, M. Pharm
- Minimum 3-6 years in the pharmaceutical industry with an emphasis on Quality Assurance.
Skills for Apotex Jobs Mumbai
- Ability to identify system improvement opportunities for data gathering, template content/format, and process efficiency.
- Expert knowledge of SAP transactions used to support the Product Review process.
- Ability to ensure timely communication of findings to key business areas.
- Ability to maintain the tracking system for compilation and review of assigned APQRs.
- Expert knowledge of international regulatory requirements that apply to Product Reviews.
- Knowledge of GMP, SOPs, regulatory requirements, and established safety standards.
- Excellent technical writing, communication skills, and interpersonal skills.
- Ability to work independently and as part of intra/inter-departmental teams.
How to Apply
Interested candidates should review the official job details and apply online through the official Apotex careers page. Candidates are encouraged to verify all details on the official application page before applying.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Conclusion
This is a valuable opportunity for qualified candidates seeking Apotex jobs Mumbai to join Apotex as an Executive in Annual Product Quality Reviews. Interested individuals are encouraged to apply at the earliest to ensure consideration for this role.
