quality engineering operation associate in Solothurn

posted
contact
Nicolae-Ionut Baias, Basel Professionals Health Care & Life Sciences
job type
contract
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job details

posted
location
solothurn
sector
life sciences
job type
contract
reference number
17890
contact
nicolae-ionut baias, basel professionals health care & life sciences
phone
058 201 55 50

job description

For our client, an international company in Solothurn we are looking for Quality Engineering Operation Associate

 
  • Start date: ASAP
  • End: 31.01.2023
  • Extension: possible
  • Workplace: Solothurn
  • Workload: 100%
 

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 Biogen 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. 

 

Tasks and responsibilities

  1. Ensure Equipment, utilities and facility design, build and qualification is successfully done according to current GMP and regulatory policies. 
  2. Review and approval of Qualification, Validation and Engineering documents during both project and operational phases of the site.  
  3. Involvement in validation and change control of the BES systems being implemented and operated at the Solothurn site.  
  4. Review of GMP documentation and data for compliance to applicable procedures, regulatory and/or corporate guidance documents.  
  5. Responsible for QA activities (Protocol deviations, test protocols, change control and QRMs) associated to equipment and automation systems in scope.

 

Must have:

  • This position requires cooperation 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. 
  • Self-driven and take ownership and responsibility for own assignments. 
  • Able to drive discussion to solve problems with cross functional teams.