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Job Description
QA Validation Specialist
Leading gene therapy company seeks experienced QA Validation Specialist to provide technical support and oversight for validation activities at manufacturing facility and QC Laboratories.
Key Responsibilities:
- Develop and maintain 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:
- 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.
- 25 days Annual Leave Plus Bank Holidays.
- Pension Employer contribution of 7.5% if employee contributes 3% or Employer contribution of 4.5% if employee decides wants to opt out.
- Discretionary performance-based bonus scheme.
- Company's share option scheme at a level commensurate with the employee's position in the company and individual performance.