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.