Assistant Manager Quality Assurance

• Perform regular In-process checks & Approve line Clearances at floor shops as per the relevant SOP and methods.
• Collect the QC Reference sample for all batches those being processed at floor shop.
• Review & verify the batch reconciliations with regards to materials, drug products, Drug Products, and packaging components.
• Review the batch documents to ensure the completeness, correctness & GMP compliances and submit to QA office for final batch release.
• Ensure the GMP compliance on shop floor & associate areas, with regards to cleanliness, housekeeping, labelling and maintenance of calibrated critical gauges.
• Ensure the GDP compliance on shop floor with regards to usage of correct & valid document timely recording of the data by appropriate user and maintenance of relevant logbooks.
• Ensure the HSE compliance on floor shop with regards to environmental conditions, personal gowning & usage of appropriate PPEs where applicable.
• Report non-compliances, Quality event and / or anomalies occurred on the shop floor.
• Active participation in the investigations of relevant failures, PTCs & implementation of CAPA.
• Perform other assignments as required to achieve department objectives.
• Participate and ensure participation of the team in Behaviour 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 audits, inspection and incidents gaps and actions, relevant to your function.
• Ensure on time reporting of all incidents including near misses and environmental incidents, to the concerned person.

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.