QA Associate (m/w/d)

Tasks :

• Responsible for Quality oversight to review and approval of validation and engineering life cycle documents (URS, FS, RTM, RA, DS, configuration spec, drawings etc.)

• 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.

Qualification:

• 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.

• 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.

• Be 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.

Requirements:

Start : 02.06.2025