Pharma Executive Quality Assurance Job at Sanofi
Welcome to Sanofi, a global pharmaceutical company dedicated to making a difference in the lives of patients around the world. We are currently seeking a Pharma Executive Quality Assurance to join our team. If you have a passion for quality assurance and a desire to contribute to the implementation and management of Quality Systems, we invite you to apply.
Time Type: Full-time
Posted On: Posted Yesterday
Job Requisition ID: R2721074
Management of Quality Systems
- Compilation, Review & Management of overall Product Quality Reviews system.
- Act as site coordinator for change controls & management of change control system.
- Management of Deviation system.
- Management of Market complaint investigation system.
- Act as QA focal point for OOS/OOT management.
- Management of Training system.
- Oversight on Pest Control system.
- To perform Nitrosamine Assessment & review.
- Management of ICHQ3D requirements.
- Site coordinator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs).
- Act as focal point for Suppliers’ management.
- Act as focal point for Subcontractors/Service Providers management.
- Act as focal point for Third-Party audit handling.
- Management of overall Validation systems (Process, cleaning, transport & computerized system).
- Management of CAPA System.
Quality Management Systems
- Coordinating for conducting self-inspection as per planner and associated self-inspection activities.
- Review and Approval of GxP documents, batch manufacturing record and batch packing record in an electronic document system.
- Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc.
- Coordination of cGMP training activity including training of the people & review of training module.
- Initiation, implementation, and closure of change controls.
- Initiation of deviation and support in deviation investigation.
- Support in Market Complaint investigation.
- Implementation of assigned CAPAs and support in closure.
- Implementation of assigned Efficiency Reviews (ERs).
- Act as PPO (Primary Process Owner) for QMI (Quality Maturity Index) as assigned.
- Batch release & response to queries from QP.
- Management of Data integrity aspects.
- Participation and support in SMS initiatives.
- Support for HSE activities.
- Handling of Site Master File (SMF).
- Calibration document review of Engineering/QC/PMTD.
- User access management & review.
- Analytical method creation.
- Audit trail review.
- Document archival/retrieval management.
Validation & Qualifications
- Quality focal point for all validations [Process, cleaning, transport & computerized system] and qualification activities.
- Quality focal point for temperature/relative humidity mapping activities.
- Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length.
- Quality focal point for utilities & purified water system.
- Management of Site Qualification & Validation Master Plan.
In-Process Quality Assurance [IPQA]
- Review & Approval of Master Batch Records & executed Batch Records.
- Review and Approval of logbooks.
- Line clearance in Production.
- To perform In-process checks in Production.
- Sampling of products during routine production and validation.
- Quality oversight on shopfloor.
- Adherence to all health safety & environmental aspects as required by company policies and procedures.
- Ensure the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
- Conduct daily training in the +QDCI meeting address any unsafe condition.
- Take suggestions from associates to improve the work conditions with great safety and zero risk.
- Periodic review of the implemented procedures and evaluation of the same.
- Train people on safety and their job to ensure zero LTI and IWLT at the workplace.
Languages: English, Hindi, Konkani, Marathi
Experience: 1-5 years of experience
Apply online for this job here.
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