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Validation Manager

Validation Manager

Job description

I am delighted to be recruiting for a permanent validation manager role with one of my top clients, based in Sligo. Knowledge in sterile/an aseptic environment is required, as well as leadership experience. In this role, you will be looking after contractors and vendors, as well as performance reviews and appraisals. There is a strong salary package on offer for the right person. 

Key Responsibilities:

  • Coordination / direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Generation, maintenance, and execution of Project Validation Plans and schedules
  • Generation of validation protocols and final reports to cGMP standards.
  • QA support for validation investigations and implementation of corrective actions.
  • Creation, review, and approval of various validation and qualification documents.
  • Management of validation, exception event, and change control processes.
  • Documenting all activities in line with cGMP requirements.
  • Performing cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • Coordinating activities to maximize the effectiveness of all of the team members.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

Education and Experience:

  • Bachelors/Masters degree in engineering or relevant scientific discipline
  • 3 years plus validation/quality experience in sterile/aseptic environment, especially in the commissioning and qualification area
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry.
  • 3 years plus of leadership experience.
  • A minimum of 3 years’ experience in a cGMP regulated environment.
  • Strong communication (written and oral), presentation and troubleshooting skills required
  • Effective interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Capable of prioritizing work and multitasking.
  • A minimum of 3 years’ experience in a cGMP regulated environment.

If you'd like to learn more about this excellent company, or about similar roles I have open at the moment, please apply here or email me directly. Looking forward to chatting.