Apotex is hiring a Senior Analyst – Annual Product Quality Review for its Mumbai location. This quality assurance role focuses on compiling Annual Product Quality Reviews (APQRs), analyzing product review data, and ensuring compliance with GMP, SOPs, regulatory requirements, and established safety standards.

Job Overview

About Apotex

Apotex is a Canadian-based global health company with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. The company is headquartered in Toronto and has regional offices globally, including in India.

Responsibilities

• Compile Annual Product Quality Reviews (APQRs) as assigned and as per applicable SOPs.
• Collect, analyze, summarize, and trend product review data accurately and completely within required timelines.
• Compile APQR sections including manufacturing process overview, batches released or rejected, APIs, excipients, changes, test methods and specifications, validation, deviations, analytical test results, recalls, returns, complaints, stability, conclusions, product rating, and follow-up recommendations.
• Perform complete and correct data transactions as per SOPs and work instructions.
• Summarize and trend analytical data from LIMS or other acceptable systems.
• Ensure the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review or Manager, QA Product Review.
• Coordinate with Project Leaders and Managers for completion of projects.
• Respond to Project Leader queries for APQR summary reports as required.
• Assist in preparation, review, and revision of Standard Operating Procedures as required.
• Ensure all work is performed in compliance with GMP, SOPs, regulatory requirements, and established safety standards.
• Work independently and as part of intra/inter-departmental teams to meet business and quality standards.
• Adhere to compliance programs including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• Perform all other relevant duties as assigned.

Qualifications

• B. Pharm / M. Pharm / M.Sc.
• Minimum 2-4 years in the pharmaceutical industry with an emphasis on Quality Assurance.
• Expert knowledge of SAP transactions used to support the Product Review process.
• Expert knowledge of international regulatory requirements applicable to Product Reviews.
• Demonstrated cGMP knowledge.
• Ability to identify system improvement opportunities for data gathering, template content/format, and process efficiency.
• Ability to ensure timely communication of findings to key business areas.
• Ability to maintain tracking systems for compilation and review of assigned APQRs.
• Strong understanding of GMP, SOPs, regulatory requirements, and safety standards.
• Excellent technical writing, communication, and interpersonal skills.
• Ability to work independently and in cross-functional teams.

How to Apply

Interested candidates can apply online through the Apotex careers page.