CQ, CQV, cGMP, manufacturing, pharmaceutical, chemical, execution, validation
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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 Lonza for C&Q execution scope under responsibilities of third parties C&Q EPC(s):
Main Areas of Responsibilities:
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.
- 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
- Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.
- 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
- A relevant Third Level or Professional Qualification
- Ability to work well under pressure and within strict deadlines
- 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)