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Job Description
The role:
PE Global is currently recruiting for QA Specialist on behalf of a leading biologics company based in Dublin North. This is an initial 12 month contract role.
Description:
- Provides support to Qualified Person (QP) for R&D supplies shipped through EU Central Warehouse (EUWH) and provides QA support to Clinical Supply Logistics.
Responsibilities:
- 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 BMS core behaviours
Education and Experience:
- 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 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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