Main 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)
·Collaborating closely with Operations, Engineering and QA department on determining qualification and requalification strategy.
· Authoring qualification documentation to ensure all tests were performed according to guidelines and the company Standards / SOPs.
· Preparation, review, approval and revision of Qualification plans and reports before and after execution.
·Ensuring that the test scope and test execution meet the requirements of the company’s Standards / SOPs.
·Ensuring that DQ (URS, GMP-RA, uCQP…) document are in accordance with Operations department requirements.
·Conducting and leading qualification and Walkdown performed with or without support of external service providers.
·Ensuring that test documentation (KNEAT or paper based) is properly filed in a CQ dossier.
·Assuring that change control of documentation and equipment complies with standards.
·Authoring DR, CAPA and Investigation in Trackwise .
·Participate to Deviation Record Board to assess impact on qualification activities
·Managing the resolution of test deviations, CAPA and TCR .
·Ensuring that test results and deviations are recorded accurately and are conform with standards.
·Authoring and reviewing Commissioning and Quality Summary Report and supervising its approval workflow.
·Plan/ organise /supervise routine requalification activities
·Preparation and participation to several audit including Swissmedic one.
Qualifications and Experience:
· Relevant working/residency permit or Swiss/EU-Citizenship required
·Higher qualification in relevant engineering discipline
·A minimum of 5 years’ experience in a similar role
·Experience in large industrial construction projects
·Communicating fluently (verbally and by writing) in English and knowledge of German is a great advantage.