Pharmaceutical Validation Specialist
We are seeking a highly skilled Pharmaceutical Validation Specialist to join our award-winning organization in Dublin.
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.
* 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.
Requirements:
* 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).
Salary: €65,000 - €90,000 per annum