Specialist - Quality Operations

Job Description:

Responsibilities

• Drafting and Authoring of Annual Monitoring and Certification report for incoming materials.
•  Drafting / Negotiation (if applicable) and Archival of Quality Assurance Agreement with
• Suppliers/Service providers.
•  Evaluation and Management of Supplier Change Notifications (SCN) and Initiation of quality record for the applicable SCN.
•  Drafting and Evaluation of Supplier’s incoming materials Specification.
•  Performing Quality Risk Assessment (QRA) for existing and new Suppliers / Service providers.
•  Management of Supplier/ Material qualification and supplier related documentation.
•  Preparation of regulatory statement for materials and finished products.
•  Management Quality records, Support the Service Delivery team (SDT) with quality topics and 3rdPAP Management in TPRM (Third Party Risk Management) tool.
•  Co-ordination with stakeholders in SIM (Supplier Information Management) approval process for Quality deliverables.
•  Evaluation of change control tasks/ deviations related to supplier quality management.
•  Coordination in handling Discrepant Materials.
•  Audit preparation support, QARP and FURP Role for audit and CAPA Management.
•  End to end deliverables for supplier quality management activities as per the delegated task from the business partner. 

Qualification & Expeirence

•  Around 8 Years
• Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university.