QA Validation Specialist

3 weeks ago

Cork, Cork, Ireland Hobson Prior International Ltd Full time

Hobson Prior is collaborating with a Biotech company that is seeking a Specialist in QA Validation. The successful candidate will oversee the production and distribution of Gene Therapy medicinal products, ensuring that processes and equipment comply with validation and qualification standards in accordance with relevant regulations.

Please note that applicants must have the legal right to work in Ireland.

Responsibilities:
  1. Prepare and maintain the site validation plan.
  2. Maintain and archive validation and qualification documentation.
  3. Collaborate with other departments to ensure validation project plans are understood and adhered to.
  4. Provide training and communicate validation standards to staff and contractors.
  5. Review and approve validation and qualification protocols and reports.
  6. Supervise project-related deviations.
  7. Assist in generating Process and Equipment Installation, Operational, and Performance Qualifications.
  8. Coordinate with external consultants, partners, suppliers, and contractors for process and equipment validation.
  9. Support data integrity compliance activities across the site.
  10. Assist in regulatory inspections and third-party audits.
  11. Ensure compliance with GxP, Data Integrity, and Good Documentation Practice (GDP), following applicable quality documents.
Key Skills & Requirements:
  1. BSc in Science or Engineering.
  2. Strong QA background in pharmaceutical or biotech sterile manufacturing environments.
  3. Extensive experience supporting validation and qualification activities.
  4. Knowledge of cell culture-based manufacturing and cellular and gene therapies.
  5. Experience with risk assessment tools such as FMEA.
  6. Ability to balance business needs with regulatory requirements.
  7. Proven success working in deadline-driven, multitasking environments.

For more information, please contact Billy O'Brien.

Apply now

If interested, click 'Apply' to upload your CV or select 'Contact me' to speak directly with a life sciences recruitment specialist.

Hobson Prior specializes in life sciences recruitment, connecting talented professionals with top positions globally. We act as an employment agency for this vacancy.

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