Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
Post : Trainee - Quality - APQR
Job Description
Job Summary
• Compile annual product quality reviews (APQRs) per applicable SOP's
• Collect, analyse and summarize product review data correctly and completely in timely manner.
Job Responsibilities
• Perform Annual Product Quality Reviews (APQRs) compilation as This includes the following at minimum, as per SOP :
* Manufacturing Process Overview
* Batches Released / Rejected
* APIs, Excipients
* Changes
* Test Method and Specification
• Manufacturing / Process Validation, Equipment and Utilities Qualification
• Sterility Validation / Qualification (If applicable)
• Packaging Component Deviations/Changes
• Compendial Review
• Deviations
• Critical In-Process Attributes
• Analytical Test Results
• Recalls and Field Alerts, Returns
• Retention Samples Review
• Technical Agreements (as appropriate)
• Marketing Authorizations Variations and Post Market Commitments (as appropriate)
• Complaints
• Stability
• Conclusion and Product Rating
• Concerns, Recommendations and Issues for Follow-Up
• Perform complete and correct transactions of the 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 the projects.
• Compile the APQRs within required timelines to ensure that there is adequate time for approvals.
• Responses 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 that 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 ensure that all work is completed in a timely manner to meet both business and quality standards.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our 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.
• All other relevant duties as assigned.
Candidate Profile
• B.Pharm/ M.Sc./ M.Pharm.
• Excellent technical writing, communication skills and interpersonal skills.
• Have the Good Academic Record from 10th Class Onwards.
• Demonstrated cGMP knowledge.
• Maintain the tracking system for compilation and review of assigned APQRs
• Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
• Perform all work in support of the Corporate values
• Minimum 1-2 years in the pharmaceutical industry with an emphasis on Quality Assurance.
Additional Information
Experience : 1-2 years
Qualification : B.Pharm, M.Sc, M. Pharm
Location : Mumbai, MH
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality - APQR
End Date : 10th December 2024
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