Senior Health and Safety Consultant
An QA Specialist is required by CareerWise Recruitment for our Cork based client. Provides effective and efficient quality assurance support to Quality Manager including supporting the implementation and maintenance of the QMS with specific focus on distribution related activities
ROLE OF THIS POSITION
- Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations and Change Controls.
- Reviews and approves SOPs/Work Instructions/Forms on behalf of Quality Assurance.
- Co-ordinates and assists in the preparation for regulatory and customer GDP inspections of the site.
- Perform GMP audits on-site and vendor facilities as required following a prearranged programme and ensure necessary corrective actions are put in place.
- To ensure compliance with the requirements of Good Distribution Practice (EU GDP).
- To perform periodic review of existing Customers and Suppliers.
- To escalate any Complaints, reported defects, reported falsified medicinal product.
- Bachelor’s Degree in a scientific/technical discipline required
- A minimum of 3-5 years’ experience in a quality or compliance role within the pharmaceutical industry, most specifically in relation to GMP and GDP.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.