QA Validation Specialist

QA Validation Specialist

CREGG are delighted to be recruiting QA Validation Specialists for a leading gene therapy company based in Shannon, Co. Clare. 

Company Information: Our client is a leading gene therapy company focused on developing innovative treatments for serious diseases. With a global presence and a state-of-the-art manufacturing facility, they are dedicated to advancing gene therapies that have the potential to transform patient outcomes.

Role Profile:

The QA Validation Specialist will be a key member of our client's team, providing hands-on technical support and oversight for validation activities at their manufacturing facility and QC Laboratories. This role is essential in ensuring that processes and equipment are validated and qualified according to industry regulations while guiding the implementation of the Site Validation Master Plan to support compliance for a new GMP facility.

Key Responsibilities:

• Develop and maintain the Irish site validation plan, ensuring alignment with regulatory and quality standards.
• Review and approve validation and qualification protocols, discrepancies, and reports.
• Provide oversight and support for project-related deviations and data integrity compliance activities across the site.
• Support Regulatory Inspections and third-party audits, ensuring compliance with applicable regulations and internal quality documents.
• Perform risk assessments and develop robust process validation plans in collaboration with Development, Operations, and QC teams.

Qualifications / Professional Skills / Knowledge

•  BSc in Science, Engineering, or a related field.
• Extensive Quality Assurance background providing QA technical support and oversight to validation and qualification activities within a pharmaceutical or biotech production environment.
• Thorough understanding of GxP compliance requirements, EU/FDA GMP guidelines, and regulations related to the qualification and validation of sterile products, aseptic processes, and systems.
• Experience with Computer System Validation (CSV) and familiarity with EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11, and CFR Part 11.
• Proficiency in risk assessment tools such as FMEA, with the ability to balance business needs against regulatory challenges.

Benefits:

• Competitive Salary. 
• Full Healthcare (Prime cover) for Self & Dependents.
• Dental Care (DeCare) for Self & Dependents.
• 25days Annual Leave Plus Bank Holidays (This is pro-rated depending on start date)
• Pension Employer contribution of 7.5% if employee contributes 3% or Employer contribution of 4.5% if employee decides wants to opt out.
• In addition to salary, employee will also be entitled to participate in our discretionary performance-based bonus scheme.
• Company’s share option scheme at a level commensurate with the employees position in the company and individual performance.

Contact Information
For a confidential discussion or to find out more, please contact:

Brendan McMahon | Recruitment Consultant – Engineering
brendanmcmahon@cregg.ie
086 1772 380 | 061 363 318