QA Qualification et Validation Expert (m/f/d)

An exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Engineer for our Biotech drug substance plant in Corsier-sur-Vevey.
As an integral member of the Quality Unit, you provide QA expertise for Process Validation and Analytical Validation:

• You elaborate the qualification/validation strategies, review and approval of protocols and reports, participates to risk analysis, identifies gap and purposes remediation plan
• You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics
• You review and/or approve qualification/validation documents, risk assessment, SOPs and take quality decisions according to company standards

The activities of the QA Expert cover all qualification/validation phases from Basic Design until 1st use of equipment/raw material.10. You ensure GMP compliance during all phases of qualification/validation.

Requirements:

• You have a university degree with at least 5 years of experience in pharmaceutical quality environment
• Proven experience in analytical methods validation and manufacturing process validation
• Strong communication and strong team spirit
• od stress resistance
• Fluent in French and English (oral & written)