Job Description
Review of documents
- Review vendor qualification /re-qualification, and supplier qualification documents and assure that documents in line with requirement stated in respective standard operating procedure.
- Review of Change Controls and accomplish assigned actions
- Perform Desk top assessment of vendor(s) as and when necessary/ assigned/ deemed.
Compliance with SOPs
- Perform evaluation of Vendor Quality Score and select vendors for Risk Based Qualification/ For Cause auditing
- Prepare Audit Schedule
- Perform Risk Based Qualification of vendors
- Follow-up with SCM for audit dates
- Follow-up with SCM for audit compliance reports
- Monitor and establish Quality and Supplier Agreements
- Perform vendor audits as assigned and produce Audit reports within stipulated time
- Prepare Re-qualification list annually
- Maintain various logs/ registers
- Prepare and update Approved Vendor/ Supplier list periodically
- Maintain Q Info records in SAP and associated transactions
- Maintain documents associated with Vendor Qualification
Customer Orientation/ Collaboration
- Shall visit USVs sites to measure compliance with the established VQ procedure.
- Shall revise SOPS as assigned and plan training for impected stackholder for its implementation.
- Shall cater vendor documents upon request from customers/ Qualified Personnel and/or Regulatory Affairs Department
- Shall assist and/or represent Vendor Qualification team during customer / Regulatory audits
- Align with R&D Project Management teams for vendor qualification activities for new projects
Problem Solving/ Investigation
- To coordinate for investigation with vendors if compliant investigation identifies necessity of an investigation from vendor
- To conduct For Cause audits
- Verify completion of proposed CAPA from vendor
- Perform Risk and Impact Assessment for reported Enforcement Actions from Regulatory Authorities by vendors.
- Summarize and document risk and impact assessment for the concluded audit schedule/ plan for the calendar year.