Executive Quality Assurance

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