CQV Leader Fill & Finish (m/f/d)
Responsibilities
- Filling and semi-stoppering (filling, dose control, closing (stoppering), sampling and rejection of vials) using Peristaltic and Piston pump dosing systems for Lyophilized vials.
- Filling Isolator (Internal environment Grade A (Iso 5), HVAC system, H2O2 decontamination process and Glove integrity tester, Rapid transfer ports for transfer of materials).
- Lyophilizers with mass spectrometer and dedicated loading and unloading isolator each.
- ATEC Stopper treatment station and loading arm into the isolator
- Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans.
- Overall planning and execution of the commissioning activities related to allocated areas or systems.
- Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
- Planning and scheduling the commissioning activities according to the C&Q strategy and supporting Validation Plans.
- Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
- Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
- Coordinating the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)
Profile
- Minimum of 10 Years extensive experience in CQV for Fill and Finish and related utilities.
- Preferably Diploma level degree in Mechanical or Chemical Engineering.
- Extensive experience with Liquid and Lyophilized vial filling lines.
- Comprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP.
Benefits
- A very renowned company
- Continuous support during the assignment
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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