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QA Qualification CAPEX Specialist

QA Qualification CAPEX Specialist

LocationStein, Switzerland
Business SectorBiotechnology
Contact nameMerel van Os
Contact email
Job ref23001
Published20 days ago
This QA Qualification Specialist within the Quality Engineering Unit will support the Project Team for the operational CAPEX readiness of a fill-finish aseptic line project in Stein (Switzerland, AG) from PQ until Swissmedic Inspection.

In order to support the strategic investments of the company in Stein (Switzerland) Global Quality Engineering is looking for an experienced Quality Engineering Specialist (f/m/d) responsible for the Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project.

RESPONSIBILITIES
  • Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
  • Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
  • Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
  • Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
  • Providing leadership and guidance to project team members on C&Q strategy and issues
  • Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
  • Escalating issues in an open and timely manner and take leadership for their resolution

PROFILE
  • Bachelor or Master's degree in Engineering, Life Sciences or related field
  • Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
  • Experience in a QA role for the C&Q of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
  • Fluent in English, German would be an advantage

PRACTICALITIES
  • Location: Stein, CH
  • Startdate: March/April
  • Duration: 6 months (high chance of extension)
  • Set-up: 41 hours per week, requires on-site support

INTERESTED?
Interviews and offers can happen this/coming week!
If you’re interested in the above description, please apply with your CV today. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at m.vanos @panda-int.com