Quality Assurance Officer

Job Title:Quality Assurance Officer

Number of Positions:04

Job Location:Ankleshwar, Gujarat

Industry:API / Pharma / Chemical Manufacturing

Experience Range:2 to 5 years in Quality Assurance within an API manufacturing company

Salary Range:3.0 LPA to 5.0 LPA

Qualifications & Required Skills:

• M.Sc. or B.Sc. in a relevant field
• Experience in Quality Assurance within an API plant
• Knowledge of wet lab analysis
• Expertise in raw material analysis
• Lab instrument calibration

About the Company:

• A well-established corporate group with over 50 years of industry experience
• A leading Indian manufacturer of pharmaceutical excipients, active pharmaceutical ingredients (APIs), and specialty chemicals
• Headquartered in Mumbai, with manufacturing plants in Gujarat and Maharashtra
• Global operations spanning North America, Europe, Asia, Africa, and South America

Job Responsibilities:

1. Issue Batch Manufacturing Records (BMR), equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packaging materials.
2. Assist in drafting and preparing SOPs for various departments.
3. Conduct plant rounds to verify documentation compliance with cGMP and GLP norms.
4. Perform line clearance activities for manufacturing and packaging before processes begin.
5. Issue deviation forms, change control forms, out-of-specification (OOS) forms, customer complaint forms, and out-of-trend (OOT) forms as requested by departments.
6. Review and verify analytical and batch manufacturing records, ensuring proper filing and QA verification for product release.
7. Prepare and monitor documentation and activities in accordance with SOPs.
8. Manage the distribution, retrieval, and control of SOPs and records across departments.
9. Participate in internal audits, customer audits, and regulatory inspections.
10. Attend quality review (QR) meetings as scheduled.
11. Ensure data integrity compliance as per established procedures.
12. Review manufacturing, storage, and quality control activities.
13. Prepare and maintain an approved vendor list and oversee vendor qualification.
14. Conduct traceability activities.
15. Maintain and update the CAPA log.
16. Investigate deviations, product recalls, returned goods, customer complaints, OOS, and OOT cases, ensuring proper documentation and CAPA implementation.
17. Collect data and prepare the annual product review.
18. Witness and verify process validation, cleaning validation, and equipment qualification, preparing necessary protocols and reports.
19. Investigate returned materials and maintain records.
20. Investigate product complaints and maintain documentation.
21. Ensure compliance with equipment maintenance and calibration schedules.
22. Prepare templates and record formats as per SOP requirements.
23. Develop and conduct training sessions on cGMP and GLP, including evaluation of training effectiveness.
24. Provide job-specific training based on identified needs.
25. Undertake additional assignments as directed by the Head of QA.
26. Ensure proper waste disposal procedures are followed.
27. Support environmental management initiatives and report progress to the department head.
28. Investigate environmental deviations/incidents in coordination with the department head.