About the Role
Currently seeking an experienced Quality Specialist to join a regulated GMP manufacturing environment in Co. Kerry. This role is focused on Quality Assurance oversight of validation, qualification and calibration activities.
The successful candidate will play a key role in ensuring all quality system activities are executed in compliance with GMP requirements, the site Validation Master Plan, and internal procedures. This is a Quality focused position with strong emphasis on documentation review, compliance assurance, and coordination of cross-functional activities.
Key Responsibilities
- Provide Quality oversight of validation, qualification, calibration, and maintenance activities
- Review and approve GMP documentation including protocols, reports, and service records
- Ensure compliance with the site Validation Master Plan and GMP regulations
- Manage and track Change Controls, Deviations, CAPAs, and related quality systems
- Coordinate with Engineering, Production, and external contractors on planned activities
- Ensure timely completion and closure of quality system records and documentation
- Support audit and inspection readiness activities
- Monitor compliance with approved procedures and escalate quality risks where required
Requirements
- Degree or equivalent qualification in Science, QA ,Engineering, or related discipline
- Experience in a GMP-regulated environment (pharmaceutical, veterinary, biotech, or medical device)
- Strong QA or Quality Systems background with exposure to validation activities
- Solid understanding of GMP principles and regulatory expectations
- Experience reviewing technical documentation and quality records
- Familiarity with CAPA, deviations, change control, and audit processes
- Strong organisational skills and attention to detail
- Exposure to validation lifecycle activities (IQ/OQ/PQ)
- Experience working with external contractors in a regulated environment
- Knowledge of EU GMP guidelines
- Experience supporting regulatory audits or inspections
What’s on Offer
- Opportunity to work in a highly regulated and quality driven manufacturing environment
- Key QA role with strong visibility across site operations
- Involvement in validation and compliance activities across multiple functions
- Competitive salary package
- Long term career development opportunities within QA and Quality Systems
How to Apply
Interested candidates are invited to apply with an up to date CV outlining relevant QA, validation, and GMP experience.
