QA Csv

Vor 5 Tagen


Visp, Schweiz Hobson Prior Vollzeit

Hobson Prior are currently looking for a QA CSV to join a brilliant pharmaceutical corporation on a contract basis located in Visp. Our client is focused on facilitating others to have a healthier life.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will be accountable for computerised system validation deliverables for new large scale mammalian establishments, equipment and utilities linked to the GMP manufacturing of biologics.
- Guarantee that CSV deliverables meet international processes, regulatory needs and policies.
- Evaluate and release quality linked CSV project deliverables.
- Serve as a SME and offer direction and suggestions to both internal and/or external project shareholders.
- You will serve as a representative of quality in CAPEX project establishments concerning CSV.

**Requirements**:

- Educated to a degree level in a computer science, engineering life science or similar discipline.
- Acquaintance with GMP regulated pharmaceutical organisation projects, ideally in a position within a quality unit.
- Know-how of CSV, data integrity and connected regulations such as 21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each.
- Familiarity with engaging with all kinds of interfaces within the corporation and with regulatory agencies such as Swissmedic, FDA, etc.
- Expertise on MES and DCS.
- Fluency in the English language with knowledge in German would be beneficial for the role.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.


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