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

  
  

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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