Officer - Quality Assurance

Roles & Responsibilities
• Monitor raw material dispensing activities in compliance with SOPs and cGMP requirements
• Perform daily IPQA activities as per defined frequencies and ensure timely closure of observations
• Carry out validation sampling as per approved validation protocols
• Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for accuracy and regulatory compliance
• Execute ERP-related IPQA transactions, preferably using SAP or equivalent systems
• Verify Batch Summary Records (BSR) and perform shipper inspections as per SOPs
• Manage issuance, review, reconciliation, and control of QA formats across departments
• Conduct regular IPQA rounds, communicate observations to HODs, and support corrective actions
• Ensure cleaning, sanitation, and hygiene practices to maintain continuous GMP compliance
• Perform sampling of In-Process materials, Semi-Finished Goods (SFG), and Finished Goods (FG) as per procedures

Qualification
• B.Pharm / M.Pharm / M.Sc in a relevant discipline

Experience
• 2–5 years of experience in IPQA or Quality Assurance within the pharmaceutical industry

Skills
• Strong knowledge of IPQA processes, cGMP, and regulatory guidelines
• Excellent documentation, review, and compliance skills
• Hands-on experience with ERP systems, preferably SAP
• Good communication and cross-functional coordination abilities
• Ability to conduct inspections, identify deviations, and support corrective and preventive actions

About the Organisation
Shalina Healthcare is a reputed pharmaceutical company with a strong global presence, committed to delivering high-quality, affordable healthcare products. The organization operates in regulated manufacturing environments and emphasizes strict GMP compliance, continuous improvement, and professional growth, offering employees hands-on exposure to quality systems and international regulatory standards.