Pharmaceutical Validation Manager
6 days ago
We are seeking a highly experienced Validation Professional to join our team in Dublin.
About the OpportunityThis 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.
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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