Quality Assurance Manager

Job Description: Quality Assurance Manager Location: Ludhiana Company: Gursimar Pharma Pvt. Ltd. Project Stage: Greenfield – Facility under setup (WHO-GMP compliant) Department: Quality Assurance Reporting To: Director Role Summary You will lead the establishment of the entire QA framework for a new pharmaceutical formulation manufacturing facility. This role is suited for someone who can build systems from zero, guide validation activities, ensure regulatory compliance from day one, and support the organization through pre-inspection readiness, scale-up, and routine operations. Your mandate is to design, implement, and maintain QA systems that are compliant, practical, and aligned with WHO-GMP, Schedule-M, and global quality expectations. Key Responsibilities 1. Quality Systems Setup & Governance Establish all QA SOPs, policies, templates, logs, and documentation structures for a new facility. Build and operationalise QMS modules: Change Control, CAPA, Deviation, OOS, OOT, Market Complaint, Recall, Supplier Qualification, etc. Ensure document control system (manual or digital) is implemented and adhered to. 2. Regulatory Compliance Ensure the facility complies with WHO-GMP, Schedule-M, CDSCO , and other relevant regulatory requirements. Conduct periodic readiness checks and internal audits to prepare for external inspections. Support dossier/technical file requirements. 3. Qualification & Validation Coordinate and review qualification protocols (URS, DQ, IQ, OQ, PQ) for equipment, utilities, and cleanrooms. Oversee process validation, cleaning validation, and analytical method validation. Ensure calibration and maintenance programs meet compliance standards. 4. Batch Release & Documentation Review Review BMR/BPRs, test reports, and ensure completeness before batch disposition. Ensure traceability, data integrity, and ALCOA+ principles across all records. 5. Vendor & Material Quality Qualify raw material, packaging material, and service vendors. Oversee sampling, specifications, COA verification, and approval processes. Lead audits of suppliers and third-party service providers. 6. IPQA & Shopfloor Oversight Implement line clearance processes for production and packing. Monitor compliance during manufacturing operations. Ensure adherence to cleaning procedures, area classifications, and environmental controls. 7. Training & Team Development Train cross-functional teams on GMP, documentation, hygiene, and QA systems. Build and mentor the QA team gradually as operations scale. 8. Risk Management Perform risk assessments (FMEA, HACCP-style) for processes, equipment, and materials. Design preventive controls to minimise compliance and product-quality risks. Required Qualifications & Experience B.Pharm / M.Pharm / M.Sc. with 6–10+ years of experience in QA for regulated manufacturing units. Hands-on experience with QMS, validations, qualification documents, and audit handling. Strong understanding of WHO-GMP, Schedule-M, GDP, and data integrity requirements. Experience in greenfield or brownfield setups is a strong advantage. Working knowledge of production processes, utilities (PW, HVAC, compressed air), and laboratory practices. Skills & Competencies High attention to detail and structured documentation habits. Ability to build systems from scratch and drive compliance independently. Good leadership and training capability. Strong communication skills for cross-department coordination. Problem-solving mindset with a practical approach to implementation. How to Apply Interested candidates may apply by sending the following documents via email: Updated CV / Resume Cover Letter explaining why you are suitable for this role and your experience with QA systems, audits, and pharmaceutical compliance Email your application to: Subject Line: Application – QA Manager