Job Description
Responsibilities
- Plan, conduct, and prepare audit reports for internal departments, subcontractors, and suppliers.
- Perform protocol, data, and report audits, including in-process inspections according to SOPs and bioanalytical guidelines (FDA, EMA).
- Review raw data and draft reports to ensure accuracy, completeness, and compliance.
- Conduct spot inspections and prepare inspection reports.
- Monitor corrective and preventive actions (CAPA) and ensure proper implementation.
- Prepare, review, and improve QA procedures and support review of departmental procedures.
- Conduct quality and compliance training sessions when required.
- Act as the main QA contact person for quality-related matters.
- Support and host client audits and regulatory inspections.
- Maintain knowledge and compliance with GCLP, GCP, GMP, CAP, ISO 17025, and ISO 15189 standards.
- Degr...