Quality Engineering Specialist - CAPEX (m/f/d)
Job ID: 12438
Entourage is a life sciences consulting firm headquartered in Munich, with additional offices in Basel, Milan, and Boston. The company features a multidisciplinary team of over 180 industry-experienced consultants who collaborate closely with leaders in the pharmaceutical and medical products industries to develop tailored solutions. Leveraging its unique hybrid approach, which combines project and management consulting, Entourage is able to offer its clients individualized solutions in the life sciences sector.
- Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
- Ensuring Commissioning and Qualification (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
- 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 Commissioning and Qualification 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
- A permanent and unlimited contract with the Entourage
- internal career and development model
- Annual budget for further training and further education
- Internal contact person for topics relating to project assignments and further development opportunities
- Schweiz
- Biotech
- Write an email
- +41615118932
- +41 79 615 10 61
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