CQV Manager (CAPEX) – 7135 in Raron

pOur client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is recruiting for a bCQV Manager - CAPEX to be based in Visp, Switzerland /b bfor an initial 12 months contract with high chances of extension. /b /p pThe CQV (Commissioning, Qualification, and Validation) Manager ensure that new equipment, facilities, and processes meet the regulatory requirements and quality standards. /p h3Main Responsibilities: /h3 ul liManage and lead a team of engineers and technicians to develop and execute CQV protocols for new equipment, facilities, and processes in compliance with regulatory requirements and corporate quality standards /li liOversee the execution of qualification and validation activities, such as installation and operational qualification, ensuring that all documentation and reports are accurate and complete /li liCollaborate with other departments, such as engineering, manufacturing, quality and regulatory affairs, to ensure that CQV activities are integrated into the project plan and completed on time and within budget /li liCalculate resource allocation, cost estimation, and timeline projection for successful CQV execution in assigned portfolio of CAPEX projects, ensuring the completion of all tasks within schedule through meetings with team members and resources to highlight and communicate schedule targets, resolve issues, and *escalate* when necessary /li liManage staffing for projects, identify and lead internal or external resources for appropriate project execution /li liOversee several remote offices which will be located in different strategic location across the globe to increase efficiency and to reduce Cost /li liAct as subject matter expert (SME) in developing Project Execution Plan and Project Quality Plan and involved committees /li liDevelop and implement commissioning, qualification, and validation (CQV) strategies aligned with global standards for CAPEX investments portfolio /li liLead CQV activities to ensure compliance with regulatory requirements and industry standards. /li liOversee project plans to ensure timely completion of CQV deliverable. /li liCollaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments /li liProvide technical leadership and guidance for CQV activities according to industry standards. /li liDevelop and maintain relationships with key stakeholders for successful project execution /li liConduct training sessions on CQV principles and best practices, identify opportunities for continuous improvement, and implement changes to optimize CQV processes /li /ul h3Qualifications and Experience: /h3 ul libRelevant Swiss working/residency permit and/or Swiss/EU-Citizenship required /b /li liMaster Degree in Pharma/Engineering/Science /li li5-10 years of experience with CQV Project Management /li liComprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP. /li liComprehensive understanding of Fill and Finish Facility Building and processes. /li liStrong leadership skills with a global interaction capability. /li liPossess financial and commercial acumen, able to link understanding to project goals, costs scheduling, and risk. /li liExperienced in calculating project-related resource needs, time, and costs. /li liExperienced as CQV-Lead and/or Project Manager. /li liMature collaboration and influencing skills, able to work efficiently in a highly matrix environment with teams and individuals. /li liStrong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions. /li liAbility to work independently and as part of a team-oriented environment. /li liAble to deal with ambiguity, conforming to shifting priorities and demands, prioritize and execute tasks in a fast-paced environment. /li liPossess strong written and oral communication skills. /li liNEAT Required , Deltav advantage /li libFluent English while German is preferred /b /li /ul #J-18808-Ljbffr