Essential Functions and Duties
- Oversee, plan, and execute the auditing process, ensuring audits and quality agreements are completed on schedule within the Quality Management System.
- Record audit findings and compile audit reports that are reviewed and distributed to the relevant management personnel.
- Ensure that the auditing function within the Quality System adheres to GMP, ISO standards, and all relevant regulatory guidelines.
- Assess audit responses, comparing them against established standards, regulations, and guidelines to verify compliance.
Qualifications
Education and Experience
- Bachelor’s degree in a scientific field.
- 4 years' experience in the pharmaceutical and/or medical device industries, with supplier auditing xp.
- Strong background in Supplier Quality Management (SQM).
- ASQ-CQA certification is a plus.
- Demonstrated expertise in conducting and managing audits.
- In-depth understanding of quality and compliance within regulated GxP/QMS environments.