QA Executive

Position: Senior Executive / Executive QA
Company: ASG Biochem Pvt. Ltd.
Location: Kolkata
Industry: API Manufacturing
Experience: 7-10 Years
Qualification: B.Pharm / M.Pharm / M.Sc. / B.Sc.

Job Summary

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.
• Strong 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.

Key Skills: QA | QC | API Manufacturing | IPQA | GMP | BMR Review | Deviation | CAPA | Change Control | OOS/OOT | HPLC | GC | Data Integrity | Audit