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CQV Lead for Aseptic Fill/Finish Lines
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CQV Lead for Aseptic Fill/Finish Lines for a 12-month contract (extension planned) based in canton Aargau, Switzerland.
- Interaction with Site Operation / Site QA / SGIE-Quality
- Leading the assigned Team of Drug Product Ancillary Equipment and Lab Equipment
- Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies
- Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
- Support / participate in validation activities during facility startup
- Provide leadership of CQV activities in assigned Project(s) in Switzerland (together with Site Operation, Site QA, SGIE-Quality):
- Responsible for ensuring that CAPEX projects are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with the company’s continuous improvement vision.
- Acting as subject matter expert on CQV standards
- Keeping oversight on CQV -standards, -timelines (etc.)
- Address immediate time/quality constraints and act adequately
- Force RFT thinking and approach
- Considering EHS Requirements
- Involved and support PM and Process Engineers in CQV-Planning:
- Development and delivery of CQV Documents
- Commissioning Documents (Suppliers / Process Engineers/EMR)
- QV-Documents (Suppliers / QV-Team /QA)
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Technical degree (Bachelor’s or Master’s) in engineering or applied science, post graduate qualification preferred.
- Minimum of 12 years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics as well as chemical manufacturing technologies desirable.
- Significant experience in qualification of aseptic filling lines and associated equipment such as vial washers, depyrogenation tunnels, filling machines, lyophilizers, cappers and isolators
- Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs.
- Fluent English is a must, Fluent in German strongly beneficial
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