Specialist - Quality Operations

Job Description Summary End to End Supplier / Vendor Quality Management Activities Job Description Supplier Quality Management: • Drafting / 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. • Preparation of relevant contributing report for respective APQR section. • 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. • Responsible for the Functional representative activities. • End to end deliverables for supplier quality management activities as per the delegated task from the business partner. Preferable Experience - Around 8 Years Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university. Languages: English. Skills Desired Collaboration, Data Integrity, Leadership, Operational Excellence