QA Specialist - Dublin
Gibbs Hybrid is looking for an accomplished QA Specialist to support a Dublin based client.
Provides support for R&D supplies shipped through EU Central Warehouse and provides QA support to Clinical Supply Logistics. The successful candidate will have a clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Compiles batch release dossiers. Supports Packaging & Labelling activities
- Provides Quality Assurance support in the Use Date Extension process and for Regional Logistics.
- Support in a timely manner, the investigations of non-conformances and quality incidents. Resolves and documents into Quality Management System deviations or problems pertaining to the review of documents. Tracks deviation and investigations
- Authors ISR related Quality agreements, keeps agreements current and manages updates required. Prepares release dossiers. Prepares and reviews procedural documents
- Support preparation of training materials. Contribute to improving and maintaining CSCQ QMS. Prepare and approve supply chain flow maps, and product specification files.
- Authoring, review, and approval of QA-related procedures
- Supporting generation of/updates existing Quality Agreements.
Essential:
- QA/ Quality assurance
- GMP experience
- Previously compiled release documents for products
- Investigating products and extensions for products
- Liaising with the warehouse and suppliers across Europe
- Oversight of logistics, liaising with depots re transport
- Previous experience of working on deviations
- Previous pharmaceutical or clinical release experience, helpful
- Preparation of documents/ training /quality agreements
- Working with stakeholders, manufacturers across the globe
- Good organisation skills
Click Apply now to be considered for the QA Specialist - Dublin role