QA Specialist

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.

The Role:

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.

Key Responsibilities:

  • 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

The Person:

  • 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 Location: Cork