Sanofi a Global Leader Supporting Peoples to meet their Health Challenges in Above 100 Countries of World with more than 100,000 Peoples

Sanofi is Looking for an Incharge  for all QC Activities of All Vaccine products at its Plant at Hyderabad, Medchal & MRP including Animal House

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Function: Quality Control Head

Roles & Responsibilities:

  • Issuance of Analytical test reports post-testing of RM, PM, Intermediates, Bulk Drugs, and Finished goods.
  • Approval of SOPs for specifications, Sampling, Testing & QC procedures, and Protocols
  • To make sure that all Validations and suitability tests are executed in accordance to appropriate methods.
  • Reference standards are prepared/procured, calibrated and Maintained in accordance with preapproved written procedures with right inventory and trending thr performance
  • Testings for Batch release and Stability studies are carried out in accordance with approved procedures and standards
  • Calibration/Qualification of all Instruments meant for testing.
  • Responsible for Analytical Life Cycle Management of methods used in commercial products testing
  • Maintaining Animal House and in-Vivo testings are in accordance with ethical, GMP & corporate standards
  • Ensuring the QC department to remain quality system compliant, Responsible to Handle OOS, OOT, Deviations, CAPA, Change Control, and Quality documentation as per predefined norms and procedures
  • Ensuring Safe Working Environment regularly.
  • Training & evaluating Analysts and Technical persons for GMP.
  • Participate in corporate initiatives like APAO, Analytical Robustness committee, Global QC council meetings (CoE) for continuous improvement of the function
  • Ensuring that the QC strategy is in line with the Company’s longterm strategy to ensure the business continuity
  • Optimizing Testing Costs and Execution of Performance Improvement Actions.
  • Responsible to implement appropriate IS  tools for lab operations viz., LIMS, SAP & other IS tools required for computer system compliance
  • Responsible to ensure compliance with Govt. agencies, local regulatory and corporate all the time
  • To identify potential quality and compliance issues in QC as part of quality risk management
  • To complete investigation and impact assessment with site quality and SME support; to define, follow up and review CAPA; to monitor the risk control and closure
  • To ensure the escalation of quality events for defining an appropriate and timely action plan
  • Development of people, leadership, multiskilling, and succession planning at all levels.

Qualification: M.Sc – Biotechnology/Microbio/M.Pharma

Experience: 15-20 Yrs in QC/QA/Production

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