Role & responsibilities :
- To plan Vendor audit annually.
- To conduct vendor qualification and periodic audits for Key Starting Material, Intermediate, and Primary Packaging Material manufacturers.
- Prepare and Review the vendor questionnaire.
- Follow up with Purchase for Vendor Audit date and respective Vendor Qualification packages.
- Review vendor qualification documentation, including questionnaires, declarations, certifications, and supporting quality documents.
- To track, prepare and maintain Quality Agreements between the sending and receiving units in compliance with GMP and regulatory requirements.
- Perform Annual Risk assessment for Vendor
- Evaluate vendor performance and support vendor approval, requalification, block or delisting activities.
- Collaborate with the Purchase department for qualification, and development of recent vendors.
- Prepare, revise, and harmonize Standard Operating Procedures (SOPs) across manufacturing sites.
- Support to initiate the QMS for Change Control, Deviations, CAPA, Vendor Management, and related quality processes.
- Follow up with the Purchase department to obtain vendor audit schedules and complete Vendor Qualification packages within defined timelines.
- Act as an Auditee for updating the response on vendor audit in E-system
- Knowledge of SAP.
Interested candidates can share resume on
[email protected]
📌 Senior Officer (Mumbai)
🏢 Harman Finochem
📍 Mumbai