Jobdescription
An exciting new 6-month opportunity has arisen tojoin us as Quality Assurance Qualification Expert for ourBiotech drug substance plant in Corsier-sur-Vevey.
Your role:
As anintegral member of the Quality Unit, you provide QA expertise forEquipment Qualification/Requalification, Sterilizationqualification, Cleaning Validation, Raw Material Qualification,Process & Analytical Validation, and Computerized SystemValidation.
The role consists to elaborate thequalification/validation strategies, review and approval ofprotocols and reports, participates to risk analysis, identifiesgap and purposes remediation plan. You act as Quality SubjectMatter Expert on specific topics and participate in riskassessments and handle deviations on these topics. You reviewand/or approve qualification/validation documents, risk assessment,SOPs and take quality decisions according to companystandards.
The activities of the QA Expert cover allqualification/validation phases from Basic Design until 1st use ofequipment/raw material.10. You ensure GMP compliance during allphases of qualification/validation.
Who you are:
* University orrelevant engineering degree
* Hands onexperience of equipment Qualification/Validation in thepharmaceutical industry
* At least 2 years’experience in a quality environment in pharmaceutical industry orequivalent, ideally in biotechnology
* Knowledgein cGMP and health authority expectations,
* Knowledge in Data Integrity will be aplus
* Experience inEquipment (Utilities/E&M/Production/Labequipment)
* Good interpersonal skills, with apositive attitude and the ability to support his colleagues in acontext of growth and changes
* Good writingskills.
* French written & spoken,English good written skills.