qa - vendor audit specialist

Required Attributes 

1. Plan, execute, and document vendor audits to ensure adherence to regulatory requirements and quality standards.
2. Ensure compliance with all applicable industry guidelines, including cGMP, ICH, EU regulations, and 21 CFR Part 11.
3. Conduct periodic reviews of vendor documentation and performance against contractual agreements and compliance requirements.Vendor Management:
4. Oversee and manage vendor relationships according to established Standard Operating Procedures (SOP).
5. Act as the primary point of contact between vendors and internal teams, ensuring smooth communication and resolution of issues.
6. Coordinate with site personnel and vendors to ensure timely delivery of goods and services.
7. Address and resolve quality-related queries raised by the site QA team.
8. Support the QA team in evaluating vendor quality systems and recommend improvements as necessary.
9. Documentation & Reporting
10. Maintain accurate and up-to-date records of vendor audits, communications, compliance status, and quality assessments.
11. Prepare detailed reports and documentation for audit trails, ensuring compliance with company policies and regulatory standards.
12. Stay informed about changes in relevant regulations and guidelines affecting vendor management and audits.
13. Provide guidance and training to internal teams on vendor-related regulations and best practices.
14. Identify opportunities to streamline vendor management and auditing processes to improve efficiency and compliance.
15. Recommend improvements to internal processes based on audit findings and vendor performance evaluations.

experience

7 ...