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For our client, a leading Swiss CMO, we are looking for a
CQV Lead (5521)
in a contractor position for initially 6 months, extension possible, onsite in the Valais in Switzerland. In this role you will support assigned project as CQV-Lead, manage CQV Engineers and define and assign needed CQV staff. You will also interact with PM / Engineering / QA and generate and plan the CQV timelines with PM.
- Technical degree (bachelor) in engineering or applied science, post graduate qualification preferred.
- 10+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics (mammalian, CGT) and chemical manufacturing technologies desirable.
- Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding and management of KPIs.
- Strong knowledge of ISPE and ASTM guidelines with proven experience on large and complex projects. Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- Experience in People Management (internal and external) with respect to organizational aspects, coaching and development.
- Proven excellent communication and interaction skills
Knowledge and Skills
- Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment.
- Excellent command of English
- Strong analytical skills. Ability to conduct in-depth analysis of complex/large data sets, draw conclusions accordingly, and prepare and support decisions.
- Experience at working both independently and in a team-oriented environment.
- Ability to effectively prioritize and execute tasks in a fast-paced environment.
- Strong written and oral communication skills.