Quality Assurance Officer- Sterile

Full time Full day

  • Ensure GMP compliance on shop floor & associated areas.

  • Ensure that all finished product are released according to SANOFI specifications

  • Ensure all deviations and other issues have been correctly documented.

  • Report non-compliances, Quality event and / or anomalies occurred on the shop floor.

  • Verify that the product has been manufactured according to local procedure, instruction and specification and in conformance of local regulatory.

  • Ensure that any change control and deviation/OOS/Validation data related with batch has been thoroughly reviewed and does not put the batch at risk.

  • Ensure collection of Samples according to SOPs & Specification.

  • Review & verify the batch reconciliations of materials, drug products and packaging components.

  • Ensure compliance of SOP’s in Manufacturing, packaging area and warehouse area.

  • Ensure the all In-Process activities on timely basis.

  • Participate and ensure participation of the team in behavior observation program of site and drive the positive change in safety culture of the site through leading the safety champion’s nomination and the reward in the area.

  • Monitor and ensure compliance of PASS achievement, Medical Screening and Surveillance and on floor safety training programs.

  • Ensure compliance with Permit To Work, Lock Out/ Tag Out, Safe Work Practices and PPEs to drive health and hygiene program of the site, related to your area/function.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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