Quality Assurance Associate III in solothurn

veröffentlicht
Kontakt
Nicolae-Ionut Baias, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
solothurn
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
17801
Kontakt
Nicolae-Ionut Baias, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

For our client, an international company in Solothurn we are looking for 

Quality Assurance Associate III

 
  • Start date: ASAP
  • End: 31.12.2022
  • 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  to enable start up, commissioning and qualification of new Large Scale Manufacturing facility. Furthermore, advise 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:

  • Good communication skills in English, verbally and written. 
  • 3-5 proven experience in related field.
  • GMP experience
  • Technically orientated, 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.
  • Confident in making technical decisions.