For our client, a leading biotechnology company, we are looking for a Quality Assurance Associate.
General Information:
- Start date: ASAP
- End Date: 01/10/2025
- Extension: possible, to be discussed
- Workplace: Solothurn
- Workload: 100% (42h/week)
- Working hours: Standard
In this role, you will be 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, deviations, change controls, work orders and any technical documentation in the scope of Facilities, utilities, equipment and 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 quality input is needed.
This position requires co-operation with people at every level of the organization and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.
...Tasks & Responsibilities:
- Ensure Equipment, utilities and facility design, build and qualification is successfully done according to current GMP and regulatory policies.
- Review and approval of Qualification, Validation and Engineering documents during both project and operational phases of the site.
- Involvement in validation and change control of the BES systems being implemented and operated at the Solothurn site.
- Review of GMP documentation and data for compliance to applicable procedures, regulatory and/or corporate guidance documents.
- Responsible for QA activities (Protocol deviations, test protocols, change control and QRMs) associated to equipment and automation systems in scope.
Your Profile:
- Good communication skills in English, verbally and written.
- Minimum Bachelor's Degree and 5+ years of similar experience.
- Experience in a technical role, including validation of laboratory, production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.
- Self-driven and takes ownership and responsibility for own assignments.
- Values 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.
- Confident in making technical decisions. In addition, must be able to prioritize tasks, be flexible and able to keep many activities running at a time.
