QA Specialist

3 months ago

Sligo, Ireland FRS Recruitment Full time

Quality Assurance Specialist (Validation)
Sligo
Pharmaceutical/Biotechnology/Manufacturing

**Job Summary:**
We're seeking a dynamic **QA Specialist (Validation)** to ensure our products meet GMP and regulatory standards. You'll play a key role in reviewing validation documents and overseeing facility, equipment, and utility qualifications. This hands-on role supports start-up and ongoing manufacturing, while ensuring compliance with the Site Validation Master Plan.

**Key Responsibilities:**
- Provide QA expertise for validation, new products, and manufacturing.
- Review and approve validation documents and equipment qualifications.
- Manage QMS areas (Deviation Investigations, Change Control, CAPA).
- Collaborate with cross-functional teams on continuous improvement initiatives.

**Requirements:**
- Bachelor's in Science/Engineering.
- 5+ years in GMP QA, supporting validation activities.
- Strong knowledge of validation lifecycle, cGMP, and quality systems.

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