Jobdescription
An exciting 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 to 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. You ensure GMP compliance during all phases of qualification/validation.
Qualifikationen
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 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 his colleagues in a context of growth and changes
* Good writing skills.
* French written & spoken, English good written skills.
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