QA Specialist
23 hours ago
QA Specialist - Ireland, Dublin - 12 Months Contract
One of the top 10 best companies to work in Ireland is looking for a QA Specialist for their large-scale new facility in Dublin. An exciting project with lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This client offers the opportunity to work within a large-scale environment with cutting edge technology.
Responsibilities
Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.
Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.
Generates and maintains Product Specification Files (PSF) for IMP.
Provides QA support and oversight of packaging and labelling operations for IMP.
Support the generation and ongoing maintenance of Quality Agreements.
Provides Quality Assurance support in the Use Date Extension process.
Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia).
Key Requirements
A degree in science, engineering or related discipline is essential along with 3 years’ experience in a role within the biopharmaceutical/pharmaceutical industry.
Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance.
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 and critical thinking skills are essential.
If this role is of interest, please apply now
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