Key skills
Communication
About this role
Role Overview
- Conduct audits of laboratory personnel
- Identify inconsistencies and operational issues
- Assess systems and work practices against applicable procedures and regulations
- Draft audit reports and conclusions and monitor corrective and preventive actions (CAPAs)
- Coordinate client and regulatory authority audits for the laboratory
- Support external auditors and respond to their queries
- Manage auditors’/inspectors’ observations and assign them to the relevant parties
- Co-evaluate the relevance of recommendations with laboratory managers
- Review study-related documentation and verify compliance with Quality Documents (Procedures, Work Instructions, …)
- Apply GMP standards and review verification protocols and reports
- Review documents specific to non-conformities (Deviations, complaints, OOX, …)
- Review quality documents such as standard operating procedures, work instructions, forms and templates
- Provide support in handling customer complaints
Requirements
- Master’s degree in a scientific field
- Minimum 2 years’ professional experience in a QA department
- Knowledge of GMP
- Good practical proficiency in French and English
- Strong powers of observation
- Analytical mindset and clear communication skills
- Ability to quickly absorb technical information (experience with Trackwise Digital)
- Comfortable using a PC (Excel, Word, PowerPoint)
- Organized, diplomatic, discreet, with a strong sense of responsibility and integrity, persistent
Benefits
- 12 RTT days per year
- Gross salary
- Meal vouchers
- Group insurance
- Hospitalization insurance (available at a reduced rate)
- Public transport pass fully reimbursed (home–work commute)
- Bike leasing