Apotex Pharma Quality Trainee Job Opening, Apply Online
Trainee – Quality – APQR
Date: Nov 18, 2024
Location: Mumbai, MH, IN, 400079
Company: Apotex
About Apotex Inc.
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.
For more information visit: www.apotex.com.
Job Summary
- Compile annual product quality reviews (APQRs) per applicable SOPs.
- Collect, analyze, and summarize product review data correctly and completely in a timely manner.
Job Responsibilities
- Perform Annual Product Quality Reviews (APQRs) compilation as per SOP, including:
- 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.
- Coordinate 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.
- 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 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.
- Work in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate behaviors 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.
- Perform all other relevant duties as assigned.
Job Requirements
Education
- B.Pharm / M.Sc. / M. Pharm.
Knowledge, Skills, and Abilities
- Excellent technical writing, communication skills, and interpersonal skills.
- Good Academic Record from 10th Class Onwards.
- Demonstrated cGMP knowledge.
- Maintain the tracking system for compilation and review of assigned APQRs.
- Perform all work in support of our Corporate Values: Courage, Collaboration, Pride, and Perseverance.
- Work 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.
Experience
- Minimum 1-2 years in the pharmaceutical industry with an emphasis on Quality Assurance.
To apply for this position, click here.
Keywords: Job Posting, Trainee, Quality, APQR, Apotex, Mumbai, MH, IN, 400079, Pharmaceutical Industry, GMP. Apotex Pharma Quality Trainee Job Opening, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
