Specialist - Quality Operations

Job Description Summary Supplier / Vendor Quality Management Activities   Job Description Supplier / Vendor Quality Management: •        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. Preferable Experience - Around 8 Years Education - M Pharma / B Pharma / MSc or Equivalent from Reputed university. Languages: English.

  Skills Desired Collaboration, Communication Skills (Inactive), Data Integrity, Digital saviness (Inactive), Leadership, Managing Ambiguity, Operational Excellence, Problem Solving Skills (Inactive), Regulatory Requirements knowledge (Inactive)