QMS Senior Specialist- Assistant Manager

Job description

JD Points:

·  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 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 of Inspection Readiness for any Regulatory Inspection.
·  Hands on handling of the different QMS tools (DMS;Trackwise;SAP;Phenix etc..)
·  Having Exposure of Quality risk managment

Qualification:

·  A minimum of Bachelor’s Degree in Pharmacy or life sciences or equivalent experience is required.
·  A minimum of 6 plus years of relevant work experience in various dosage forms. Experience in Injectable Pharmaceuticals is a plus.

             Exposure to domestic and international GMP regulatory inspections or audit is a plus.

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.