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.
Duties
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)