• To assure that Drug Products manufactured, packed, stored and released for sale as per the required Quality standards and regulatory requirement, through process monitoring.
• To improve overall GMP conditions at the site through implementation of Quality systems.
• To ensure compliance with applicable regulatory requirements.
• Ensure quality oversight activities of QA Non Sterile (pharma Soild and liquid) and ensure proper cGMP compliance in area
• Ensure all issues of floor to be rectified on time for smooth business continuity
• Ensure all batches of Non sterile products to be released on time.
• Ensure management of master batch documents and controlled documents of site.
• Reviewing /authorization of relevant SOPs, MMR, BMRs, BPRS, BMPR
• Implementation of Global Quality Directive procedures and guidance on shop floor.
• Ensure all Investigation of internal and external complaints are completed on time.
• Ensure all deviations of site to be completed on time
• Co-ordinating training to officers, workers to achieve better results in achieving quality products.
• Ensure quality oversight activities in warehouse and ensure to maintain GMP .
• Ensure implementation of good storage practices in warehouse.
• Support in the execution of annual Quality Roadmap and provide input for better execution
• Ensure timely implementation and closure of all CAPA of site as per assigned timelines.
• Ensure on time investigations closure for all deviations of QA non sterile .
• Ensure APR is carried out as per approved annual plan and as per procedure.
• Provide necessary support during all Quality Audit, Regulatory Inspections and site visits.
• Support Quality team for Pro Active Risk Management and mitigation strategies.
• Play due role in enhancing Quality Culture at shop floor
• Participate and ensure participation of the team in Behavior Observation Program of site and drive the positive change in Safety Culture of the site through leading the safety champions nominations and reward in the area.
• Monitor and ensure compliance of PASS achievement, Medical Screening and Surveillance and on floor safety training programs.
• Ensure compliance with Permit To Work, Lock Out/Tag Out, Safe Work Practices and PPEs to drive health and hygiene program of the site related to your area/function.
• Ensure on time CAPA closure for all HSE audits, inspection and incidents gaps and actions.
• Ensure on time reporting of all incidents including near misses and environmental incidents.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Company Website : Sanofi Global (English) (Link)