Direct message the job poster from Atrium (EMEA)
Contact me for job opportunities: dnguyen@gibbsconsulting.com
Contract – Quality Assurance Specialist – Dublin/Hybrid - 12 months - PAYE
We are currently supporting one of our pharmaceutical client based in Dublin and looking for:
* Role: Quality Assurance Specialist
* Location: Dublin/Hybrid
* Job type: Contract
* Duration: 12 months
Duties/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 labeling 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)
* Supports in a timely manner, investigations of non-conformances and quality incidents as QA. Resolves and documents in the Quality Management System quality. Conducts appropriate follow-up, as required. Tracks deviation, investigations and CAPAs.
* Generate and complete QA review of supplier/customer qualification documentation for the
* Responsible Person (RP). Ensure supplier/customer qualification and re-qualification is complete within required timelines.
* Provide support to Health Authority inspections and internal audits as required.
* Prepares and reviews procedural documents.
* Complete Change control assessment and CAPA evaluation/CAPA close-out
* Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
* Support OPEX programs and champion continuous quality improvement initiatives.
* Skills/Qualifications:
* 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.
Please feel free to contact myself – Daisy Nguyen (dnguyen@gibbsconsulting.com) at Gibbs/ Atrium UK for a confidential chat to know more details about the role.
Please also note: Due to the volume of applications received for positions, it will not be possible to respond to all applications and only applicants who are considered suitable for interview will be contacted.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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