Claims Quality Assurance Officer

4 days ago

India Gursimar pharma pvt ltd Full time

Quality Assurance Manager Location: Gursimar Pharma Pvt. Project Stage: Greenfield – Facility under setup (WHO-GMP compliant) Department: Quality Assurance 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. 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. 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. Ensure traceability, data integrity, and ALCOA+ principles across all records. Vendor & Material Quality Qualify raw material, packaging material, and service vendors. Implement line clearance processes for production and packing. Monitor compliance during manufacturing operations. Training & Team Development Train cross-functional teams on GMP, documentation, hygiene, and QA systems. Build and mentor the QA team gradually as operations scale. 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 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. Good leadership and training capability. Problem-solving mindset with a practical approach to implementation. Cover Letter explaining why you are suitable for this role and your experience with QA systems, audits, and pharmaceutical compliance Subject Line: Application – QA Manager

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