QA Qualification Specialist

At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced QA Qualification Specialist.

Job description

• For our client located in the Basel area, you will be:Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project.

• Ensure 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.

• Review and approve C&Q documents of GMP systems as well as related changes and deviations.

• Support audits and regulatory inspections (Swissmedic, FDA, etc.).

• Provide leadership and guidance to project team members on C&Q strategy and issues.

• Ensure that decisions are fully supported by global and local Quality, as well as Regulatory.

• Escalate 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.

Benefits

• Between 30% and 70% remote work in agreement with your manager and client needs (40% for cross boarders due to tax regulation)

• Options to order ergonomically proven equipment (monitor & chair) for your home-office premises

• Support for trainings, formation upon agreement with the manager

• Contribution on gym subscription

• Trust-based managerial culture

• Team rituals and get togethers

We look forward to receiving your application. Capgemini Engineering only accepts direct applications (no recruitment agencies). Due to Swiss regulations we only consider Swiss or EU/EFTA applicants or applicants with a valid work permit.