Responsibilities:
- Contributing to the achievement of Quality objectives while maintaining compliance with current Good Manufacturing Practices (cGMP).
- Performing quality control activities across QC, Incoming Quality Assurance (IQA), and Metrology functions.
- Conducting incoming, in-process, and final product testing in line with approved specifications and procedures.
- Identifying, escalating, and supporting the resolution of quality events and potential quality issues.
- Maintaining accurate, compliant, and audit-ready Quality System documentation.
- Supporting internal quality audits and driving compliance across the business.
- Assisting with Change Management activities, including the review and update of product and Quality System documentation.
- Producing quality metrics and reports to support management reviews and monitor overall Quality performance.
- Ensuring training requirements are maintained and up to date.
- Actively participating in continuous improvement initiatives to enhance quality, safety, environmental, and manufacturing performance.
- Preparing batch records to support manufacturing process orders.
- Making disposition decisions for incoming materials in accordance with quality requirements.
- A third level qualification in an appropriate discipline is desirable.
- 2+ years' Experience within a regulated GMP environment is desirable.
- 1 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment is desirable.
For a confidential discussion on the role and the organisation, please contact Emma Barry today.
emma.barry@collinsmcnicholas.ie
091 706719
