CQV Lead

Proclinical are recruiting for a CQV Lead to join a biotech organisation. This role is on a contract basis and is located in Stein.

Responsibilities:

• Guide coordination meetings to fine-tune the commissioning preparation and implementation with all included parties.
• Lead the C&Q documentation effort to guarantee precision, accomplishment and alignment across various areas/systems.
• General planning and implementation of the commissioning actions linked to assigned areas or systems.
• You will report the C&Q status, progression and concerns throughout project shareholder meetings such as Tier 1 meetings, Wall meetings etc.
• Assist with the updates of Master C&Q plan and assist with plans throughout the project implementation lifecycle.
• Produce, evaluate, approve, CQV tests scripts rendering to verification plans and any other suitable site commissioning or validation plans or processes.
• Arrange and interfacing with vendors for C&Q implementation linked actions.
• Guarantee discrepancies encountered are precisely evaluated and approved rendering to CORP-35.
• Contribute to construction walk-downs and punch-listing of these systems for mechanical completion.
• Other duties may be assigned.

Key Skills and Requirements:

• A pertinent third level or professional qualification.
• Works well while under pressure as well as in strict deadlines.
• At least 10 years of experience within areas/systems under future accountability.
• Educated to a degree level in a mechanical or chemical engineering.
• Familiarity with field CQV implementation.
• Acquaintance with cGMP.
• Interpersonal and communication skills both verbally and in writing.
• Fluency in the English language with knowledge in German.
• Prior involvement using Kneat for documentation and implementation.

If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at +41 61 508 73 40.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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