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.