Job Description
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 will provide QA expertise for Equipment Qualification/Requalification, Sterilization qualification, Cleaning Validation, Raw Material Qualification, Process & Analytical Validation, and Computerized System Validation.
Key Responsibilities:
* Elaborate qualification/validation strategies;
* Review and approval of protocols and reports;
* Participate in risk analysis and identify gaps for remediation plans;
* Act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics;
* Review and/or approve qualification/validation documents, risk assessment, SOPs, and take quality decisions according to company standards;
* Ensure GMP compliance during all phases of qualification/validation.
About You:
We are looking for a candidate with the following qualifications and experience:
* University or relevant engineering degree;