Head of Cqv - Wrexham, United Kingdom - Proclinical

Proclinical
Proclinical
Verified Company
Wrexham, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Proclinical are recruiting for a Head of CQV to join a biotech organisation. This role is on a permanent basis and is located in Europe.


Responsibilities:


  • Guide CQV projects, which involves planning, scheduling, and implementing, to guarantee that projects meet timelines and goals.
  • You will drive constant improvement initiatives in CQV procedures, strategies and systems to grow efficiency.
  • Recognise and acknowledge concerns that raise throughout CQV actions, offering technical knowledge and assistance to resolve challenges.
  • Supervise and arrange the implementation of validation protocols, which involves IQ OQ, PQ.
  • Perform risk examinations and impact analysis linked to equipment, procedures, and facility changes and develop mitigation methods.
  • Responsible for developing and executing methods for the CQV procedures in line with organisation best practices and regulatory needs.
  • Work alongside crossfunctional teams, which involves Engineering, Manufacturing, QA, and RA to assure seamless integration of CQV actions with any other divisions.
  • Other duties may be assigned to this role.

Key Skills and Requirements:


  • Demonstrable experience in CQV in the pharmaceutical, biotechnology or medical device organisation.
  • Comprehension of cGMP, FDA, EMA, and any other regulatory necessities linked to Commissioning, Qualification, and Validation.
  • Project management abilities with acquaintance in guiding CQV projects from inception to completion.
  • Leadership capabilities with the ability to resolve issues,
  • Communication skills both verbally and in writing.
  • Expertise on riskbased approaches and strategies for CQV procedures.
  • Works well with others within a crossfunctional team setting.


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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