Quality Assurance Associate
A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
- 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 Execution System (global and local computerised 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 and Requirements
- This position requires co-operation with people at every level of the organisation and from multiple functions, including engineering, automation, validation and Manufacturing personnel
- Good communication skills in English, verbally and written.
- Technically orientated role including experience of the validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.
- Self-driven and take ownership and responsibility for own assignments. Value teamwork at all levels, performs work with an open-mind and ability to value input from colleagues and peers. Able to drive discussion to solve problems with cross functional teams.
- Be confident in making technical decisions. In addition must be able to prioritise tasks, be flexible and able to keep many activities running at a time.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.