Apotex is inviting applications for the role of Executive, GBS Quality APQR in Mumbai, Maharashtra. This Quality Assurance position is suitable for candidates with experience in APQR compilation, GMP compliance, SOP-based documentation, product review data analysis, and pharmaceutical quality systems.

Job Details

Job Description

The Executive, GBS Quality APQR will be responsible for compiling annual product quality reviews as per applicable SOPs. The role involves collecting, analysing, summarizing, and trending product review data accurately and within required timelines.

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.

Key Responsibilities

• Compile annual product quality reviews (APQRs) as assigned and as per applicable SOPs.
• Review APQR elements including manufacturing process overview, batches released or rejected, APIs, excipients, changes, test methods and specifications.
• Compile information related to manufacturing or process validation, equipment and utilities qualification, and sterility validation or qualification where applicable.
• Review packaging component deviations or changes, compendial review, deviations, critical in-process attributes, analytical test results, recalls and field alerts, returns, retention samples, complaints, and stability data.
• Include technical agreements, marketing authorization variations, post-market commitments, product rating, conclusions, concerns, recommendations, and follow-up issues as appropriate.
• Perform complete and correct transactions of data as per SOPs and work instructions.
• Summarize and trend analytical data from LIMS or other acceptable systems.
• Ensure completed APQRs are 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 assigned projects.
• Compile APQRs within required timelines to allow adequate time for approvals.
• Respond to Project Leader queries related to 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 with intra/inter-departmental teams to complete work on time while meeting business and quality standards.
• Ensure personal adherence with 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.

Qualification

• B. Pharm/ M. Pharm/ M.Sc
• Expert knowledge of SAP transactions used to support the Product Review process.
• 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 maintain tracking systems for compilation and review of assigned APQRs.
• Excellent technical writing, communication, and interpersonal skills.
• Ability to work independently and as part of intra/inter-departmental teams.

Experience

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

How to Apply

Interested candidates can apply online through the official Apotex careers link below.