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



vendor, generic and finished product codes in ERP.
• Coordinate equipment identification and Equipment ID allocation.
• Review and approve short-expiry and MRP-related activities in ERP, as applicable.
• Coordinate documentation for COPP, manufacturing licences, regulatory certificates and product permissions, and maintain relevant records.
• Ensure compliance with applicable cGMP, Schedule M, WHO-GMP, USFDA and other relevant regulatory requirements.
• 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