- Work with subject matter experts to keep the site inspection-ready, organizing resources and materials, and provide input on correspondences with the regulatory authorities.
- Lead internal audits for the site's compliance to GMP regulations
- Establish and renew Quality Agreements with suppliers, monitor supplier audit results/responses, and on occasion, participate in audits of suppliers.
- Manage the cross-contamination risk assessment process, evaluating the risk of change requests to the site's product portfolio and facilities.
- Write and peer-review investigations, risk assessments, and root cause analysis related to product post-market surveillance and complaints.
- Participate in monthly and quarterly routines for the site's compliance, including the site's quality council, annual product reviews and related sub-reports, and various trending reports.
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