QA Analyst – Dublin

Desired Skills: batch release,quality assurance,qms

PE Global is currently recruiting for QA Analyst on behalf of our client based in North Dublin: 12 month initial contract

Principal Objective of the Position
Provides support to Qualified Person (QP) for R&D supplies shipped through EU Central Warehouse (EUWH) and provides QA support to Clinical Supply Logistics.

The successful candidate will hold a BSc in Science or related discipline, with relevant QA or related experience in a Pharmaceutical environment. A clear understanding of cGMP requirements for manufacturing and/or systems and compliance. The candidate should also be open to travel in support of their role, where necessary.
 
The QA specialist will be required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential. The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.

Key Responsibilities and Major Duties
• Compiles Qualified Person batch release dossiers
• Supports Packaging & Labelling activities performed at EUWH.
• Provides Quality Assurance support in the Use Date Extension process.
• Provides Quality Assurance support (GMP/GDP guidance and training) for CSO 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. Conducts appropriate follow-up as required. Tracks deviation, investigations and CAPAs.
• Authors ISR related Quality agreements, keeps agreements current and manages updates required.
• Prepares release dossiers for ISRs
• Prepares and reviews procedural documents as requested by supervisor.
• 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.
• Adherence to core behaviours
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net