Hiring a QA professional with hands-on experience in both QA and QC from an API/pharmaceutical manufacturing environment.
Key Responsibilities
- IPQA and GMP compliance across manufacturing operations.
- Review of BMR/BPR, SOPs, specifications and quality documents.
- Handling of Deviation, CAPA, Change Control, OOS/OOT and investigations.
- Support internal, customer and regulatory audits.
- Review of validation/qualification and APQR/PQR documents.
- Ensure GDP and Data Integrity compliance.
- QC experience in sampling, testing and analysis of raw materials, in-process samples and APIs.
- Working knowledge of HPLC, GC, KF, UV,
FTIR and other analytical instruments.
- Coordination with Production, QC, Engineering and other departments on quality matters.
Required Experience & Skills
- Mandatory experience in both QA and QC.
- Solid exposure to API manufacturing / bulk drug industry.
- Good knowledge of GMP, GLP, GDP, Data Integrity and pharmaceutical quality systems.
- Experience in OOS/OOT, deviations, CAPA and change control.
- Regulatory/customer audit exposure will be an added advantage.