Apotex is inviting applications for the role of Executive – Annual Product Quality Reviews in the Quality Assurance department at Mumbai, MH, IN, 400079. This opportunity is suitable for candidates with experience in pharmaceutical Quality Assurance, APQR compilation, GMP compliance, SOP-driven documentation, and product review data analysis.

Apotex is a Canadian-based global health company with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. The company has regional offices globally, including in the United States, Mexico and India. For more information, candidates may visit www.apotex.com.

Job Details

Job Description

The selected candidate will be responsible for compiling annual product quality reviews, also known as APQRs, as per applicable SOPs. The role involves collecting, analysing and summarizing product review data correctly, completely and within required timelines.

This Quality Assurance role requires strong documentation discipline, knowledge of regulatory expectations, and the ability to work with analytical data from LIMS or other acceptable systems.

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 and 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.
• Co-ordinate with Project Leader(s) – QA Product Review / Manager for completion of projects.
• Compile APQRs within required timelines to ensure adequate time for approvals.
• Respond to Project Leader’s queries for APQR summary reports as required.
• Assist in preparation, review and revision of Standard Operating Procedures (SOPs) as required.
• Ensure all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards.
• Work both independently and as part of intra/inter-departmental teams to meet business and quality standards.
• Work in a safe manner while collaborating as a team member to achieve outcomes.
• Demonstrate behaviours aligned with organizational values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the 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.

Qualification

• M.Sc
• MBA
• B. Pharm/ M. Pharm/ M.Sc

Experience

Minimum 3-6 years in the pharmaceutical industry with an emphasis on Quality Assurance.

Required Knowledge, Skills and Abilities

• 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.
• Ability to ensure annual product reviews are performed in full compliance with current procedures.
• Expert knowledge of international regulatory requirements that apply to Product Reviews.
• Knowledge of GMP, SOPs, regulatory requirements and established safety standards.
• Demonstrated cGMP knowledge.
• Excellent technical writing, communication skills and interpersonal skills.
• Ability to work independently and as part of intra/inter-departmental teams.

Benefits and Workplace Support

Apotex has stated that it is committed to fostering a welcoming and accessible work environment, where everyone feels valued, respected, and supported to succeed.

The company offers accommodation for applicants with disabilities as part of its recruitment process. If contacted to arrange an interview or testing, candidates may advise Apotex if accommodation is required.

How to Apply

Interested candidates should review the official job details and apply online through the official Apotex careers page.

Candidates should verify all details on the official application page before applying.

Author: PharmaBharat Editorial Team