Position: Trainee – Quality APQR
Company: Apotex Inc.
Location: Mumbai, Maharashtra, India
Industry Type: Pharma/Healthcare/Clinical Research
Functional Area: Quality – APQR
Application End Date: 10th December 2024
Job Summary:
- Compile APQRs as per SOPs, ensuring timely and complete data analysis and summaries.
- Coordinate with QA Project Leaders/Managers to complete projects within deadlines.
- Address queries related to APQR summary reports.
- Maintain compliance with GMP, SOPs, and regulatory requirements.
- Assist in SOP preparation, review, and revision as needed.
- Work collaboratively as part of a team and maintain adherence to safety and compliance standards.
Key Responsibilities:
- Compilation: Review various data, including manufacturing processes, batch records, deviations, and analytical test results.
- Validation: Include information on process and equipment qualification, sterility, and packaging component changes.
- Summarization: Trend data from LIMS or approved systems.
- Reporting: Submit APQRs for review and ensure approval by QA leaders.
- Documentation: Maintain SOPs and adhere to corporate values (Collaboration, Courage, Perseverance, Passion).
Candidate Profile:
- Education: B.Pharm, M.Sc., or M.Pharm.
- Experience: Minimum of 1-2 years in the pharmaceutical industry, specifically in Quality Assurance.
- Skills:
- Strong technical writing and communication skills.
- Knowledge of cGMP and QA practices.
- Excellent teamwork and independent working ability.
- Good academic record from 10th grade onward.
- Values: Demonstrates behaviors aligning with Apotex’s values of collaboration, courage, pride, and perseverance.
Additional Information:
- Compliance: Maintain adherence to global ethics, quality policies, and safety/environment standards.
- Experience Level: 1-2 years in a relevant field.