QA Validation Specialist

Walker Cole International is supporting an exciting opportunity within a leading biologics manufacturing site in the appointment of a QA Validation Specialist for a Bulk Drug Substance facility.

This opportunity will play a key role in providing end-to-end quality oversight across manufacturing, testing, documentation, and product disposition within a GMP-regulated environment.

Key responsibilities:

• Provide QA and cGMP oversight across all commercial manufacturing activities within the BDS facility.
• Review and approve executed and master batch records, including electronic batch records, as well as validation documentation (cleaning, process, and analytical methods).
• Review and approve SOPs, work instructions, technical reports, and protocols, and provide QA oversight for quality risk assessments.
• Support inspection readiness activities and act as a key contact during health authority inspections.
• Oversee core QMS elements, including deviations, change control, calibration, and preventive maintenance.

Required experience and skills:

• Experience within the pharmaceutical or biotech industry.
• Strong understanding of GMP, quality systems, and regulatory expectations.
• Ability to work effectively in a complex, international matrix environment.
• Strong communication and presentation skills.
• Proven ability to influence cross-functionally and demonstrate leadership.
  
  

Working pattern:
Full-time Onsite

Employment type:
Contract

Location:
Dublin

Duration:
12 months

Keywords:
QA Specialist | Quality Assurance | GMP | Biologics | BDS | Batch Release | QMS | Deviations | Change Control | Validation | Pharma | Biotech

ID:
102247