Our client is seeking a QA Manager to fill an existing position in West Dublin. They are a pharma facility with a strong, inclusive culture and some very interesting projects on the horizon.

Responsibilities:

• Ensuring GMP and GLP on site
• Review and approval of QMS related documentation for compliance with GMP
• Preparation for and participation in both customer and regulatory inspections
• Preparation of Annual PQRs
• Process Deviation Report management including implementation of effective corrective actions
• Managing Customer Complaints ensuring all complaints are addressed promptly & thoroughly
• Monitoring of supplier performance and evaluation / auditing of suppliers and potential suppliers
• Management of GMP documentation
• Preparation and approval of standard operating procedures (SOPs)
• Review of batches prior to release by a Qualified Person
• Archiving of batch documentation and reference samples
• Management of recalls and the generation of mock recall reports
• Induction GMP training and training plan preparation
• Experience in implementation of continuous improvement initiatives

Responsibilities:

• A degree in life science or another related field
• A Postgraduate qualification which allows the candidate to act as a Qualified Person
• 5+ years working in a similar role
• A good understanding of regulatory requirements.
• Experience with ISO 13485 device standards is desirable


If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747