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CQV Qualification Lead – 5476
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 Qualification Lead based in Stein, Switzerland.
The CQ Lead is responsible for overseeing the defined CQ scope of his process area and meeting the agreed objectives regarding time schedule and functionality according to URS, Risk Assessments and Verification Plans. The C&Q Lead will act as representative for C&Q execution scope under responsibilities of third parties C&Q EPC(s):
- 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.)
- Guiding the C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems.
- Lead the preparation activities for commissioning activities start-up.
- Coordination and interfacing with vendors for C&Q execution related activities. Also ensuring the execution is completed in accordance with CORP-35 principles.
- Guiding and overall oversight of the Commissioning field execution, including protocols execution. Coordinating the interface of test specifications
- Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties
- Reporting of C&Q status, progress and issues during project stakeholders meetings (e.g. Tier 1 meetings, Wall meetings).
- Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.
- Ensure discrepancies encountered are adequately reviewed and approved in accordance with CORP-35. Tracking of these deficiencies, including planning and executing the remediation actions
- Assist the C&Q Manager with the Handover and Release process.
- Leads the management of change for his area elements and ensures that the change is controlled, communicated and implemented in the most cost effective and timely manner
- C&Q execution milestones are completed as per baseline schedule
- Supporting the commissioning field team with specific process tasks
- Ensures C&Q field execution is completed in a safely manner and following HSE standards. This will include overall oversight of Lock-Out-Tag-Out preparation, PSHR completion, Method Statements, and Start-up activities.
- Liaising with Construction on design and construction issues.
- Participate in construction walk-downs and punch-listing of these systems for Mechanical Completion.
- Ensure that quality standards are followed during C&Q execution. No significant observations in external regulatory inspections for allocated process area.
- Support the C&Q execution team as Kneat Super User.
- CUB and PU Buildings Black Utilities: Instrument Air, Black Steam reduction and distribution Systems, Chilled and Cooling Water Systems, Sanitary systems, Drinking/Heating water systems, etc.
- PU Building Clean Utilities: Compressed Air, Nitrogen, Softened Water, Purified water system, Clean Steam Generation and Distribution, WFI Generation and Distribution.
- HVAC and Clean Rooms (all buildings)
- Warehouse and QC Buildings Utility distribution systems (Clean and Black Utilities)
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- A relevant Third Level or Professional Qualification
- Ability to work well under pressure and within strict deadlines
- Minimum of 10 Years extensive experience in areas/systems under future responsibility.
- Preferably Diploma level degree in Mechanical or Chemical Engineering.
- Field CQV execution experience.
- Considerable experience with cGMP
- Strong interpersonal and communication skills.
- Good Level in English, written and spoken / German a plus.
- Experience in use of Kneat for documentation development and execution (not mandatory)
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.