Head of Quality Assurance - Injectable

Self- driven professional with strong experience in leading the quality function. A person who provides overall leadership to Quality function covering Quality Assurance, Quality control and Micro dept. Bring strong quality culture and any time audit readiness with strong change management skills Contribute to company’s strong aspirations to cater regulated markets ensuring compliance and successful audits from authorities of EU, Australia (APVMA), US FDA (CVMA), Saudi Arabia (MSA) etc covering all production lines.  Manage, control and sustain seamless manufacturing operations of the formulation unit, in order to meet the manufacturing targets as per business requirements in compliance with cGMP, safety and allocated budget. Manage handling of Injectable commercial products (Liquid-Aseptic & Terminal sterilized, Lyophilized, Dry Powder, Ophthalmic Products) as well as new products, Scale up batches and EB batches  Ensure all SOPs are well drafted inline with latest international regulations and GMP norms and adherence of the same at ground level.  Have strong governance and control mechanism on product dispatches to customers and ensure no recalls.  Strengthen overall QMS at factory and provide guidance to new site.  Timely review of vendor audits collaborating with purchase dept, strengthen IPQA and overall QMS system.  Have strong experience in managing quality compliance and successful audits for injectable lines.  Establish new systems and drive continuous improvements through Quality focused initiatives to reduce production cost, quality by design and facilitate smooth & safe operations.  Support Regulatory providing timely documents for registrations – New products as well as queries on existing products dossiers.  Monitor adherence to standards and statutory compliance through periodic reviews to avoid accidents & for compliance as per government norms.  Ensure cGMP compliance of the unit by building, assessing and tracking the systems and controls at unit to meet regulatory and customer requirements.  Ensure maintenance of facility and qualification of equipment by collaborating with engineering.  Present the QRM to management. Must have experience in managing more than 20 quality professional team members. Ensure minimum quality complaints with appropriate CAPA submission in time.  Ensure overall training program being run effectively. The designee can bring change in overall training plan/preparation and execution. Show more Show less