Apotex Hiring Trainee in QA
About Company:
Apotex Inc. is a Canadian-based global health company producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees, Apotex operates in manufacturing, R&D, and commercial sectors, offering medicines in over 75 countries. Specializing in generic, biosimilar, and specialty products, Apotex is committed to global healthcare.
Position:
Trainee, GBS Quality APQR
Organization:
Apotex
Qualification:
B.Pharm, M.Pharm, MSC
Experience:
1 to 2 Years
Salary:
₹25,000 – ₹35,000 / month
Location:
Mumbai
Job Summary:
Compile annual product quality reviews (APQRs) per applicable SOPs. Collect, analyze, and summarize product review data accurately and timely.
Job Responsibilities:
- Compile APQRs including Manufacturing Process Overview, Batches Released/Rejected, APIs, Excipients, Changes, Test Method and Specification, etc.
- Perform accurate data transactions as per SOP/WIs.
- Summarize and trend analytical data from LIMS or other systems.
- Ensure complete APQR submission for review and approval.
- Coordinate with Project Leaders for project completion.
- Compile APQRs within required timelines for approvals.
- Respond to Project Leader’s queries for APQR summary reports.
- Assist in preparation, review, and revision of SOPs.
- Adhere to GMP, SOPs, regulatory requirements, and safety standards.
- Work independently and in teams to meet business and quality standards.
- Demonstrate behaviors of Collaboration, Courage, Perseverance, and Passion.
- Adhere to compliance programs, quality policies, safety standards, and HR policies.
- Perform all other relevant duties as assigned.