Qualified Person
TR/078443
Posted: 29/07/2025
- Competitive
- Ireland, County Meath, Dunboyne
- Contract
Orion Group Life Sciences are currently recruiting a QP on behalf of our Multinational Biopharmaceutical Client based in Meath on an initial 6-Month contract with potential to extend.
Hybrid role.
What you will do:
EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures. BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.
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.
Hybrid role.
What you will do:
- Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
- Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations and/or technical agreement.
- Manage and/or escalate any potential CGMP and/or other concerns in a timely manner.
- Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material.
- Confirm change requests with product impact which require expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed.
- EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
- Expert level of knowledge of relevant GMPs, regulations and current industry trends. Communication, decision making, people influencing and project management skills.
- Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues
EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures. BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline.
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.
Jordan Robb
Recruitment Consultant
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