Specialist - Quality Operations
Novartis•2d ago
Hyderabad (Office)OnsiteFull-timeMid Level8+ yrs exp
Top focus
Operations AnalystOperations ManagerOperations Consultant
- 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, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge