Quality Engineering Specialist

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  1. Contract
  2. English
  3. Associate
  4. Engineering & Technical Services
  5. Basel Region
  6. Healthcare & Life Sciences


QA, Qualification, Capex, Quality Engineering, Commissioning & Qualification, C&Q, Compliance, GMP

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On behalf of our client, an international pharmaceutical company based in Switzerland, Swisslinx is looking for a Quality Engineering Specialist. This is a contract initially for 6 months (extension is highly possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.

- Start date: As soon as possible
- Duration: 6 months
- Extension: highly possible
- Location: Stein
- Workload: 100%

This is a QA Qualification Capex role within the Quality Engineering Unit and will support the Project Team for the operational readiness of a fill-finish aseptic line project in Stein from PQ until Swissmedic Inspection.

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

Key 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

Your 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

For further information or to apply please do not hesitate to contact Alina Peeva, Senior Recruiter: alina.peeva@swisslinx.com

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