Quality Assurance Manager

Role Overview: As the Quality Assurance Manager at Gursimar Pharma Pvt. Ltd. in Ludhiana, you will be responsible for leading the establishment of the entire QA framework for a new pharmaceutical formulation manufacturing facility. Your role involves building systems from scratch, guiding validation activities, ensuring regulatory compliance, and supporting the organization through pre-inspection readiness, scale-up, and routine operations. It is crucial for you to design, implement, and maintain QA systems that are compliant, practical, and aligned with WHO-GMP, Schedule-M, and global quality expectations. Key Responsibilities: - Establish all QA SOPs, policies, templates, logs, and documentation structures for the new facility. - Build and operationalize QMS modules such as Change Control, CAPA, Deviation, OOS, OOT, Market Complaint, Recall, Supplier Qualification, etc. - Ensure implementation and adherence to the document control system, whether manual or digital. - Ensure regulatory compliance with WHO-GMP, Schedule-M, CDSCO, and other relevant requirements. - Conduct periodic readiness checks and internal audits to prepare for external inspections. - Coordinate and review qualification protocols for equipment, utilities, and cleanrooms. - Oversee process validation, cleaning validation, and analytical method validation. - Review BMR/BPRs, test reports, and ensure completeness before batch disposition. - Qualify raw material, packaging material, and service vendors. - Implement line clearance processes for production and packing. - Train cross-functional teams on GMP, documentation, hygiene, and QA systems. - Perform risk assessments for processes, equipment, and materials and design preventive controls. Qualification Required: - 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, and laboratory practices. Please note that the job description does not include any additional details about the company.,