QA Specialist
Senior QA experience particularly in Batch Release, Distribution/Warehouse, Review/submission of Technical paperwork, Annexe 21.
Manage and Maintain the Quality Management System (QMS) ensuring it is fit for purpose under EU GMP and GDP regulations
Approve SOPs and Quality System Documentation to support QP release of DP under EU importation
Prepare, Update & Review Technical Agreements with partners and third parties
Support HPRA inspections and prepare written responses
Oversee Quality aspects of new product introduction
Review and approve non- conformances, CAPAs, Change Controls and Complaints
Manage Supplier and Customer GDP compliance reviews
Ensure GMP- compliant batch record packs for release
Conduct Internal Audits and Management Reviews
Lead the implementation of continuous improvement initiatives within Quality operations
Knowledge:
Must be familiar with EMA & FDA regulations; ICH and WHO guidelines - Preferable knowledge of CMC stage gates and submission types.
Understand European and Rest of world regulatory requirements, guidelines, and expectations.
Be up to date with respect to the current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP).
Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
The person will report into our Senior QP and will not have any direct reports.