About Your New Employer
* Clinical-stage gene therapy company focused on developing potentially curative treatments for serious diseases
* Work with a company that has a significant impact on the patient care.
* Benefit from a collaborative and inclusive culture that values your contributions.
About Your New Job as QA Validation specialist:
* Prepare and maintain the Irish site validation plan.
* Maintain and archive Validation/Qualification documentation.
* Interface with departments such as Engineering, QC Laboratories, Operations, Supply Chain, and Process Development to ensure validation project plans are understood and adhered to.
* Communicate and provide training in the required validation standard to staff and contractors.
* Review and approve validation, qualification protocols, and reports.
* Provide oversight to project-related deviations.
* Maintain understanding of cGMP, Good Engineering Practices, and guidance in relation to all aspects of validation across manufacturing, laboratories, and facilities.
* Support generation of Process and QC Equipment Installation, Operational and Performance Qualifications, and review and approve the Qualification protocols, discrepancies, and reports for Quality.
* Interface with external consultants and partners as directed by QA Validation and Materials Supply Manager, suppliers, and contractors to ensure successful process and equipment validation.
* Provide QA support to data integrity compliance activities across the site.
* Support Regulatory Inspections and third-party audits.
What Skills You Need for QA Validation Specialist:
* Established track record in delivering robust and regulatory compliant Validation Plans and Protocols.
* Extensive experience of GxP compliance requirements.
* Ability to interact with other departments and personnel across the business both verbally and in writing, demonstrating good interpersonal skills.
* Ability to identify and escalate issues to line management, ensuring workload is prioritized.
* Ability to respond flexibly and adapt to the needs of the department/wider business.
What’s on Offer for QA Validation Specialist:
* Competitive salary.
* Benefits, Training & Development, Career Path.
* Opportunity to work in an ambitious, deadline-driven environment and handle multiple tasks simultaneously.
What’s Next
Apply now by clicking the “Apply Now" button or call me, Karolina on 091749267. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.
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