Responsibilities: Coordinate and control the service providers and suppliers, the individual work steps as well as the material flows. Subject Master for Utilities and HVAC qualification (Clean and black). Collaborate closely with Operations, Engineering, and QA departments on determining qualification and requalification strategy. Author qualification documentation to ensure all tests were performed according to guidelines and company Standards / SOPs. Prepare, review, approve, and revise Qualification plans and reports before and after execution. Ensure that the test scope and execution meet the requirements of the company’s Standards / SOPs. Ensure that DQ (URS, GMP-RA, u CQP...) documents are in accordance with Operations department requirements. Conduct and lead qualification and Walkdown performed with or without support of external service providers. Ensure that test documentation (KNEAT or paper-based) is properly filed in a CQ dossier. Assure that change control of documentation and equipment complies with standards. Author DR, CAPA, and Investigation in Trackwise. Participate in Deviation Record Board to assess impact on qualification activities. Manage the resolution of test deviations, CAPA, and TCR. Ensure that test results and deviations are recorded accurately and conform with standards. Author and review Commissioning and Quality Summary Report and supervise its approval workflow. Plan, organize, and supervise routine requalification activities. Prepare for and participate in several audits, including Swissmedic. Qualifications and Experience: Relevant working/residency permit or Swiss/EU citizenship required. Higher qualification in a relevant engineering discipline. A minimum of 5 years’ experience in a similar role. Experience in large industrial construction projects. Fluent communication (verbal and written) in English; knowledge of German is a great advantage.
#J-18808-Ljbffr