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With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Position: QMS Senior Specialist- Assistant Manager
Location: Toopran Mandal, Telangana
Job Description:
- Handling & Execution of Supplier Management (Qualification) Activities.
- Preparation of the list of Approved Suppliers / Vendors.
- To Perform Supplier annual performance review (SAPR).
- Preparation / Establishment of Quality Agreement (QTA) with Supplier / Vendor.
- To Perform and Initiation of auditor qualification as per the procedure.
- Handling of Deviation / CAPA / Change Control
- Handling of supplier complaints.
- Preparation of the Event/CAPA/Change control trending.
- Handling of Market compliant/Product complaint and participate in its Investigations.
- Responsible for the Preparation of Self-Inspections schedule & Self-Inspection execution as per the schedule.
- Responsible for the timely closure of self-inspection observations and its reports.
- Participation, Coordination, and support during Regulatory inspections.
- Having exposure to Inspection Readiness for any Regulatory Inspection.
- Hands-on the handling of the different QMS tools (DMS; Trackwise; SAP; Phenix etc..)
- Having Exposure to Quality risk management
- Exposure to Domestic & International GMP requirements is preferred
Qualification: B.Sc/B.Pharma & Above
Experience: Minimum 6 Years in Various Dosage Forms, Parenteral is added Advantage
Salary: Negotiable
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