QA Validation Engineer - CDmax until 31.12.2024 - 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 s / Vevey.

As an integral member of the Quality Unit, you provide QA expertise for Process Validation, Analytical Validation, Cleaning Validation, Raw Material Qualification.

You elaborate the qualification / validation strategies, review and approval of protocols and reports, participates to risk analysis, identifies gap and purposes remediation planYou 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. Your profile : 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 spiritGood stress resistanceFluent in French and English (oral & written)