Our client is a global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life.
Our client requires a QA Specialist to join the Quality team on site in Cork on a 12-month fixed term contract. In this role, you contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
- Implementation, maintenance and development of QA systems
- Reviewing the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc, and Exceptional Documents eg. NCRs/PNCRs, Planned Deviations etc.
- Internal Auditing and external auditing
- Participation in change control activities on site
- Assist in the preparation and reviewing of QA department reports and metrics eg. monthly quality report, discrepancy reports, exceptions reports, KPI reports
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients
- Assist in preparation and presentation of GMP training programmes
- Assist in New Product Introduction Activities when required
- Contribute to the quality assessment of clinical, pre-commercial product, and to the quality assessment of commercial finished product
- Degree in science or quality
- Minimum 3 years pharmaceutical experience in a regulated environment preferable
- Knowledge of GMP
To learn more apply online or contact Orla Boyle at HRM directly on +353 91 782110 for a confidential chat.
Salary: On Application