QA Qualification Expert
vor 1 Woche
An exciting new 6-month opportunity has arisen to join us as Quality Assurance Qualification Expert for our Biotech drug substance plant in Corsier-sur-Vevey.
Your role:
As an integral member of the Quality Unit, you provide QA expertise for Equipment Qualification/Requalification, Sterilization qualification, Cleaning Validation, Raw Material Qualification, Process & Analytical Validation, and Computerized System Validation. The role consists of elaborating the qualification/validation strategies, reviewing and approving protocols and reports, participating in risk analysis, identifying gaps, and proposing remediation plans. You act as a Quality Subject Matter Expert on specific topics, participate in risk assessments, and handle deviations on these topics. You review and/or approve qualification/validation documents, risk assessments, 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 materials. You ensure GMP compliance during all phases of qualification/validation.
Who you are:
- University or relevant engineering degree
- Hands-on experience of equipment Qualification/Validation in the pharmaceutical industry
- At least 2 years’ experience in a quality environment in the pharmaceutical industry or equivalent, ideally in biotechnology
- Knowledge in cGMP and health authority expectations
- Knowledge in Data Integrity will be a plus
- Experience in Equipment (Utilities/E&M/Production/Lab equipment)
- Good interpersonal skills, with a positive attitude and the ability to support colleagues in a context of growth and changes
- Good writing skills
- French written & spoken, English good written skills
Kata Kulcsár
- Lausanne Professionals Life Sciences
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