Orion Group Life Sciences are currently recruiting a QP on behalf of our Multinational Biopharmaceutical Client based in Tipperary on an initial 11-Month contract with potential to extend.
1 day per week onsite.
What you will do: Bring energy, knowledge, innovation and leadership to carry out the following:
- The QP will be involved in the review and certification of batches intended for use in clinical trials, to ensure compliance with EU GMP, the Product Specification File and the Clinical Trial Application.
- This role will encompass product manufactured across the company Global Supply Chain and subsequently imported into the EU. Products include Small Molecules, Large Molecules - Biologics, Vaccines, Gene Therapy etc
- The QP will be involved with Health Authority Inspections to maintain the site licences, audits both internal and external.
- This role will also be involved in ongoing compliance activities related to clinical trials, for example technical and quality agreements with collaborators, stock recovery activities etc.
What skills & qualifications you will need:In order to excel in this role, you will more than likely have:
- Eligible to be named as a Qualified Person (QP) and to have maintained CPD.
- Practical experience with disposition of product types such as Sterile, Nonsterile, Biologics, Vaccine, Gene Therapy or ATMP, is preferable. Including at least two year's experience in quality assurance or qualitative analysis of related medicinal products. Familiarity with EudraLex Chapter 4, Annex 13, Annex 16 and applicable EU CTR regulations 536/2014.
- A recognised pharmacy degree course at a third level institution in Ireland or if the pharmacy course has been completed outside of Ireland evidence of Pharmaceutical Society of Ireland registration and acknowledgement from the EU competent authority where the pharmacy degree was completed to meet the educational requirements of Article 49 of EU Directive 2001/83/EC and Article 97 of the EU Regulation 2019/6.
- An academic qualification at least equivalent to a level 8 primary course in a scientific discipline and has successfully completed a recognised post-graduate course in Ireland that satisfies the educational requirements as defined in the EU Regulation 2019/6 and the EU Directive 2001/83/EC.
- Extensive experience in a cGMP environment, preferably gained in a Quality function with respect to clinical trials/IMP environment.
- Experience with conducting audits and hosting inspections.
- Dynamic individual with excellent organizational skills, who can work effectively and proactively on global functional teams.
- Effective verbal and written communication skills in collaborating to colleagues and associates both inside and outside the organisation.
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.
