Main responsibilities:
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 coordinaator for Implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs)
- Act as focal point for Subcontractors/ Service Providers management.
- 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 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.
HSE
- Adherence to all health safety & environmental aspects as required by company policies and procedures.
- Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
- Conducting daily training in the +QDCI meeting address any unsafe condition.
- Take suggestion 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 workplace.
Languages : English, Hindi, Konkani, Marathi
- Qualification : B.Pharm / M.Pharm
Experience -3-5 years experience
