CQV Lead

vor 2 Wochen

Basel, Schweiz Coopers Group AG Vollzeit
CQV Lead

Do you have a strong experience in qualification and validation of equipment and in a pharmaceutical manufacturing environment?

Our client in Stein needs your support and offers exciting projects and responsibilities.

Duration: end of 2024

Main responsibilities:

Ensure that CQV activities are executed, the C&Q Plan and supporting Validation Plans.
C&Q SME warehouse scope - cold and ambient.
Support C&Q execution for key euipment (Semiautomated and fully automated visual inspection machine), other small support equipment (thawing units, fridges, freezers, cold /freezer rooms)
Coordination of execution activities with supporting CSV Team and global IT teams.
Lead C&Q testing activities supported by external vendors and/or contractors.
Develop any supporting validation plans related to scope of execution.
Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
Interface and with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering
Generate, review, approve, CQV test scripts in accordance with verification plans and any applicable site commissioning or validation plans or procedures.
Lead 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
Ensure C&Q execution milestones are completed as per baseline schedule
C&Q field execution completed in a safely manner and following Lonza HSE standards. This will include preparation of Lock-Out-Tag-Out, PSHR completion, Method Statements.
Support the C&Q execution team as Kneat Super User.

Your background

Minimum of 8 Years extensive experience in areas/systems under future responsibility.
Preferably Diploma level degree in Mechanical or Chemical Engineering.
Previous experience in authoring CQV lifecycle documents necessary
Previous experience in qualifying warehouse (ambient and 2 to 8 degree cold room) necessary
Field CQV execution experience.
Considerable experience with cGMP
Experience in use of Kneat for documentation development and execution

Sounds like a great job?
Then we look forward to receiving your complete application documents through our online application form.

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