23789 QA COE Specialist
CR/079139
Posted: 17/09/2025
- Competitive
- Ireland, County Dublin, Dublin
- Contract
Orion Group Life Sciences are currently recruiting a QA Specialist (Centre of Excellence) on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend.
This position will report directly to the Quality Assurance COE Lead for Biotech Dublin.
With energy, knowledge & innovation, the QA COE Specialist will:
General
Technical & Education
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
This position will report directly to the Quality Assurance COE Lead for Biotech Dublin.
With energy, knowledge & innovation, the QA COE Specialist will:
- Support various site functional and cross functional tier structures.
- Completes review and approval for CAPAs, change requests, and investigative protocols and final reports.
- Responsible for the quality aspects of material and supplier management, such as compilation of material qualification pack, supplier audit review, supplier management system upkeep.
- Involved in the development and review of documentation and quality records in collaboration with other stakeholders such as QC, MS&T, Engineering and Warehouse throughout the product lifecycle e.g. method validation, facility upgrades, qualification protocols, calibration records.
- Review and approve GMP documentation / data for accuracy and completeness.
- Working cross functionally to ensure projects milestones are met in a timely manner.
- Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
General
- A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Strong collaboration and cross-functional leadership skills.
- Strong verbal and written communication skills, project management skills.
Technical & Education
- Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
- 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
- 2 years of experience in performing the release function in a regulated environment
- Strong knowledge of qualification and implementation of Single Use technologies and raw materials for use in a GMP environment.
- Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
- Proven track record in delivering excellence.
- Knowledge of SAP, KNEAT and Veeva system is an advantage.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Aoibhinn Daly
Recruitment Consultant
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