Our client, a biotech company in Solothurn area is looking for a Quality Assurance III
contract until 31.08.2021 with possibility of extensionDescription:
Responsible for Quality oversight to review and approval of validation and engineering life cycle documents (URS, FS, RTM, RA, DS, configuration spec, drawings etc), test protocols, CAPAs, deviations, change controls, work orders and any technical documentation in the scope of Facilities, utilities, equipment and client Execution System (global and local computerized systems) to enable start up, commissioning and qualification of new Large Scale Manufacturing facility. Furthermore advice the project groups as appropriate and be an active member of the groups where the quality input is needed.Skills:
- more than 4 years experience in quality assurance in pharma or biotech environment
- MSc in Life Science or Engineering
- Ability to cooperate with people at every level of the organisation and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME's on equipment and knowledge of biotechnology API production.
- Good communication skills in English, verbally and written.
- Experience with Capa and Change Control
- Experience of the validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.
- Open-mind and ability to value input from colleagues and peers. Able to drive discussion to solve problems with cross functional teams.
Randstad (Schweiz) AG