Officer - QC

Job Responsibilities:

• Perform routine analysis of raw materials, in-process, finished products, and stability samples for SVP (Sterile Injectable / Small Volume Parenterals).
• Operate and maintain analytical instruments such as HPLC, GC, UV, IR, Dissolution, TOC, and KF.
• Ensure all analysis is carried out as per cGMP, SOPs, pharmacopeial methods, and regulatory requirements.
• Review and prepare analytical documents, COAs, and reports.
• Handle OOS, OOT, deviations, and participate in root cause analysis with CAPA implementation.
• Coordinate with QA, Production, and Regulatory Affairs for compliance and timely release of products.
• Support in method validation, equipment qualification, and laboratory investigations.
• Prepare for regulatory inspections (USFDA, MHRA, EU, WHO, etc.) and ensure compliance.
• Train and guide junior analysts in QC practices, data integrity, and safety.

Desired Candidate Profile:

• Sc (Chemistry) / B.Pharm / M.Pharm with 36 years of QC experience in SVP (Sterile Injectable / Parenterals).
• Hands-on experience in HPLC, GC, and other QC instrumentation.
• Strong understanding of GMP, data integrity, and regulatory guidelines.
• Good analytical, documentation, and problem-solving skills.