We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
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
• Drive Operational Excellence and Champion Change
• Determine validation strategy and outcome of validation activities
• Decision to approve or reject validation documentation
• Provide Validation position on related topics and strategy for the site
Education & Experience
• 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)
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or firstname.lastname@example.org for further information.