Responsible for Vendor Qualification Program.
Prepare vendor audit schedules and conduct supplier qualification, requalification and for cause audits.
Review vendor qualification documents, QTAs and questionnaire to comply with Standard OperatingProcedure.
Communication with internal and external stakeholders for vendor qualification activity e.g. SCM, SiteQuality, Vendor etc.
Review and update SOP to ensure compliances as per current regulatory requirements.
Ensure GMP and DI compliances at vendor sites as per cGMP requirements for USFDA, EU market.
Perform periodic evaluation of vendors based on material criticality, material category and type ofsupplies.
Support in regulatory submission for vendor quality documentation.
Periodic review with vendor representatives to discuss on the quality issue and requirements.
Support sites during regulatory inspections as QA representative (SME) for functional area.
Support vendors to achieve quality compliances as per PPL and regulatory requirement.

📌 Manager Quality Vendor Management Mumbai
🏢 Piramal Pharma
📍 Mumbai