QA Specialist - Dublin - Gibbs Hybrid : Job Details

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