Role & responsibilities :

1. Lead the implementation, maintenance, and continual improvement of the Pharmaceutical Quality System (PQS) in line with applicable GMP requirements, Quality Policy, regulatory guidelines, and approved quality standards.
2. Ensure effective implementation and control of quality systems, including SOPs, specifications, batch manufacturing records, batch packing records, protocols, quality manuals, and other GMP-related documentation.
3. Oversee In-Process Quality Assurance (IPQA) activities and exercise the authority to initiate, monitor, suspend, or stop manufacturing operations based on quality risks, GMP compliance, and product quality requirements.
4. Review and approve quality-related documents and reports, including deviations, change controls, CAPA, OOS/OOT investigations, risk assessments, validation protocols and reports, stability reports, APQR/PQR, batch records, and other quality system documents.
5. Ensure effective monitoring and control of manufacturing environments, plant hygiene, in-process quality checks, equipment qualification,



process validation, calibration, preventive maintenance, and other activities that may impact product quality.
6. Ensure the appropriate approval or rejection of starting materials, packaging materials, intermediates, bulk products, and finished products, and support the timely review and disposition of batches in accordance with approved procedures.
7. Lead investigations related to market complaints, product recalls, batch failures, laboratory incidents, deviations, non-conformities, and quality events, and ensure timely implementation and effectiveness monitoring of corrective and preventive actions.
8. Plan and conduct internal audits, self-inspections, supplier and service-provider audits, and support regulatory, customer, and third-party audits while ensuring timely closure of audit observations and compliance commitments.
9. Develop and strengthen the QA team through manpower planning, te

📌 GM Quality Assurance (Vapi)
🏢 WOW Softech
📍 Vapi