Specialist - Quality Operations

Job description

Job Description

Summary End to End Supplier / Vendor Quality Management Activities

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)