Quality Assurance Officer| Pharmaceutical| Hybrid |Perm| Westmeath
Great opportunity for a Quality Assurance Officer to join a dynamic and growing Pharma company based in Athlone, County Westmeath. The role will also offer a great opportunity for involvement in new projects and product launches into the European market.
The role is open to a hybrid model.
Quality Assurance Officer responsibilities:
- Quality Assurance responsibility for document change control, complaints & CAPA management within the organization
- Maintain Quality Management System processes in line company procedures
- Monitor investigation timelines for quality issues e.g. non-conformance and Issuance and archiving of quality documentation
- Report out key process indicators (Document Change Control, Complaints & CAPA)
- Support preparations for internal and external audits
- Aid in the investigation and evaluation of audit findings
- Ensure root causes are appropriately identified and corrective actions are verified for effectiveness
- Review records and documents for completeness and compliance with GMP/GDP requirements and internal organizational procedures
- Participate in interdepartmental initiatives for continuous improvement of procedures, processes and systems and maintain a list of compliance initiatives
- Take on any further reasonable responsibilities as assigned to you by your manager
Quality Assurance Officer requirements:
- Bachelor's degree in any Life Science, Biomedical, or related field (or equivalent work experience)
- Minimum of 2 years relevant experience. within the pharmaceutical sector is essential
- Good understanding of cGMP, 21 CFR Part 211, and related regulations associated with pharmaceutical product control
FULL SPEC ON APPLICATION**
For a confidential discussion and more information on the role, please contact Tina Cornally.