À propos de ce poste Specialist - Quality Operations chez Novartis
Band
Level 3
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 & Supplier Complaints.
• 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, Communication, Data Integrity, Digital Fluency, Good Manufacturing Practices (GMP), Internal Quality Auditing, Managing Ambiguity, Operational Excellence, Problem Solving, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC)