Our client, a leading healthcare company, is keen to hire a Plant Compliance Manager to join their growing team in Cavan on a permanent basis.
The Plant Compliance Manager will ensure that compliance is managed effectively and will provide leadership in the areas of plant compliance, strategic compliance initiatives, compliance initiatives, cGMP, and food safety.
Key Responsibilities (Full job description available on request):
- The Plant Compliance Manager is accountable for ensuring the site is always audit ready for all external audits (regulatory auditors include FDA, GACC, SAMR etc).
- Responsibility in providing direction for continuous improvement within the plant.
- Ensure compliance with all AQR and Division Policies.
- Responsible for ensuring cGMP best practices throughout the plant and developing programmes to continually improve plant practices.
- Lead strategic quality initiatives in the areas of Line Clearance and other specific areas.
- Management of the Risk Assessment process on site.
- Play a key role in the Plant Validation Review Board to ensure all new equipment/processes and any new infrastructure meets cGMP standards and regulatory compliance.
- Bachelors degree in the relevant field.
- 6+ years specialising in Regulatory Affairs.
- Experience working in a highly regulated environment.
- Understanding the quality regulations required in an audit.
- Very good understanding of the manufacturing process.
- Strong knowledge and experience in risk management, validation, microbiology, analytical techniques, and methods used.
For a confidential discussion and more information on the role, please contact Sarah Flynn