Pharmaceutical Validation Manager

6 days ago


County Dublin, Ireland Life Science Recruitment Full time

We are seeking a highly experienced Validation Professional to join our team in Dublin.

About the Opportunity

This is an excellent position for anyone looking to join a top pharmaceutical company who are one of the best at what they do.

Key Responsibilities:
  • Validation oversight of External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities.
  • Validation document author/approver.
  • Ensure validated parameters are correctly incorporated in Master Batch Records.
  • Regulatory - Aseptic processing system oversight (media fill, autoclave validation, EM) content authorship.
  • Validation change control assessment.
  • Perform Person in Plant activities as required.
  • Author applicable MA filing sections.
  • Write/review RTQs.
  • Prepare inspection playbooks.
  • Present on topics during inspection demonstrating appropriate behaviours and knowledge of the subject areas.
Requirements

To be successful in this role, you will need:

  • Degree qualified in science and/or engineering.
  • 5 + years (ideally 8 years +) biotech or pharmaceutical industry experience.
  • Significant Validation experience at Aseptic Manufacturing or API facilities.
  • Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn't first language).


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