Beschreibung
Location: Southern Switzerland, 100% on-siteDuration: min 6 months
Job Description:
In this role, the worker will be responsible for cleaning validation in the biopharmaceutical plants, including cleaning qualification, validation activities at scale, and periodical cleaning reviews.
Key responsibilities:
- Ensure QA oversight for Cleaning Design activities to a Large Scale Cell Culture Mammalian Facility
- Define and review CIP strategy approach with the design and CQV team according to the procedure and in compliance with regulatory guidance.
- Technical lead of cleaning validation teams including communication with customers, as appropriate.
- Support / review / approve QC cleaning studies.
Key requirements:
- Bachelor, Master degree or PhD in Analytical Science, biotechnology, chemistry or related field
- Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within the Quality Unit (QA, QC)
- Strong background in cGMP
- Broad knowledge in cleaning validation of biopharmaceuticals & Biologics
- Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
- CAPEX project experience (greenfield project would be beneficial)
- Excellent verbal, written and interpersonal communications skills
- Fluency in English, German would be an advantage
Keywords: Cleaning Qualification, Cleaning Validation, QA, Quality Assurance, Qc, Quality Control, Change Control, Deviations, Cleaning Review, Switzerland, Schweiz, Life Sciences, Biotechnology, Chemistry, Pharmaceuticals, German, English, Bern, QA Manager Cleaning Validation
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.