Key Responsibilities

1. Manage vendor qualification, evaluation, approval, periodic review and vendor-related documentation.
2. Plan, coordinate and conduct vendor and external agency audits, ensuring timely closure of audit observations.
3. Manage internal audits, regulatory inspections and external audits, including preparation and submission of compliance responses.
4. Prepare, review and maintain Quality Technical Agreements (QTAs) with vendors, customers, clients and external laboratories.
5. Prepare, review and control SOPs and other QA-related documents.
6. Manage Change Controls, CAPAs, Deviations and Incidents, ensuring timely investigation and closure.
7. Handle market complaints, product quality investigations and product recall activities.
8. Participate in self-inspections and coordinate audit compliance with relevant Cross-Functional Teams (CFTs).
9. Review Annual Product Quality Reviews (APQRs) and Continuous Process Verification (CPV) reports.
10. Manage QA-related computerized systems, troubleshooting, compliance and audit trail reviews, ensuring data integrity.
11. Coordinate product registration and regulatory submissions by providing required quality and technical documentation.
12. Review product artworks, shade cards and Bills of Material (BOM).
13. Ensure appropriate creation, authorization, modification and blocking of material,



vendor, generic and finished product codes in ERP.
14. Coordinate equipment identification and Equipment ID allocation.
15. Review and approve short-expiry and MRP-related activities in ERP, as applicable.
16. Coordinate documentation for COPP, manufacturing licences, regulatory certificates and product permissions, and maintain relevant records.
17. Ensure compliance with applicable cGMP, Schedule M, WHO-GMP, USFDA and other relevant regulatory requirements.
18. Undertake any other QA-related responsibilities assigned by the Head – Quality Assurance.

Educational Qualification

- B.Pharm / M.Pharm / M.Sc. in a relevant discipline.

Experience

- 10–14 years of experience in Quality Assurance within the pharmaceutical industry.
- Relevant experience in sterile injectable manufacturing is mandatory.
- Exposure to regulatory audits, QMS, vendor management and computerized systems.

Required Technical Competencies

- Knowledge of sterile manufacturing, aseptic processing and EU GMP Annex 1.
- Understanding of cGMP, USFDA, WHO-GMP and Schedule M requirements.
- Expertise in QMS, CAPA, Deviations, Change Control and audit management.
- Knowledge of contamination control strategy (CCS), data integrity and computerized systems.

📌 Manager – Quality Assurance (Nalagarh)
🏢 Immacule Lifesciences
📍 Nalagarh