Our client is a leading global biotechnology company. They have best-in-class products in a number of therapeutic areas.
They are seeking a QA Specialist for a global role with diverse responsibilities and a clear career path. Experience in Biologics is a big advantage. The position will require approximately up to 20% travel.
Reviewing batch documentation, data, certificates of analyses, and providing support to the QP function
Supporting schedule adherence of material disposition
Designing and implementing quality systems relating to batch disposition
Maintaining and improving quality metrics
Approving and leading deviation investigations, change control assessments, CAPA implementation, investigations and non-conformance reviews.
Supporting QC activities as they relate to product disposition.
Supporting the investigation of drug product complaints and support any recall efforts in conjunction with QP
Conducting external audits independently as lead auditor
Author and implement Quality Agreements
Supporting Annual Product Quality Review
Participating in technology transfer, process scale-up, and process improvement projects.
Supporting integration activities relating to product disposition
Experience of working in Quality Assurance role to support the manufacturing of medicinal products.
Thorough understanding of quality systems and GMP.
Lead auditor experience / qualification
Must be able to travel up to 20% (domestic and international)
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747