QA Specialist
Next Generation View all jobs
- Dublin
- Contract
- Full-time
- Laboratory investigations, deviations, and associated corrective and preventive actions (CAPAs)
- Contract testing laboratory investigations and related documentation
- Operational SOPs, test methods, forms, and quality directives
- Annual Product Reviews (APRs) and trending reports
- Laboratory equipment and instrumentation qualification protocols and reports
- Method validation and technical transfer protocols and reports
- Change control documentation impacting QC activities
- Establish and promote best practices and continuous improvement initiatives in partnership with Quality Systems and Compliance teams
- Ensure all QC activities comply with applicable policies, procedures, guidance documents, and global regulatory requirements
- Support QC laboratories during global regulatory authority inspections and market approval activities
- Contribute to the execution of the internal audit programme
- Support QC and QA Network Harmonisation initiatives across the organisation
- BSc in Science (or related discipline) with 3+ years' Quality experience in the biopharmaceutical/pharmaceutical industry
- Strong knowledge of cGMP laboratory compliance and equipment/instrument qualification
- Excellent communication skills with the ability to work independently and within cross-functional, matrixed teams
- Highly organised, adaptable, and capable of managing multiple priorities in fast-paced environments.