Our client, a global biotechnology company that employs over 20,000 people across the world, is looking to hire a Senior QA Specialist Contractor (IMPs). The company specialise in creating breakthrough therapies for rare diseases, and works to produce an innovative pipeline acrosstheir key therapy areas. This is a contract role based in Dublin, Ireland.
- To provide QA support for the manufacture, packaging, labeling, and control of clinical trial materials manufactured by company contractors to ensure compliance with GMP requirements.
- To provide QA support for the analytical performed at contract laboratories for commercial and developmental/clinical use.
- To perform GMP release of IMP and ensure compliant release to global markets as appropriate.
- To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and CTA requirements.
- To review and approve master records labels and protocols. Actively participate in project meetings as required.
- To be knowledgeable about the products supplied for clinical trials.
- To ensure that all appropriate batch related documents and finished packs are available from contractors/suppliers in order to enable release of products.
- Provide GMP certification/release of IMP ensuring global compliance.
- To participate in the QA auditing programme of contractors/suppliers to ensure compliance with GMP and be knowledgeable about the main contractor sites used by the company to provide IMP and those performing analytical work on behalf of the company.
- To support and maintain the relevant Technical Agreements.
- To communicate with contractors/suppliers regarding technical information and queries.
- Ensure deviations/OOS are adequately investigated and documented.
- Ensure clinical complaints are adequately investigated and reported.
- To ensure that the documentation systems to support Clinical/Analytical QA activities are maintained.
- To prepare and/or update standard operating procedures and to ensure all Clinical/Analytical QA SOPs are reviewed in a timely manner.
- To participate in the GQA self-inspection programme concerning clinical GMP areas as appropriate.
Education & Experience:
- University degree or equivalent in Chemistry, Biology, Pharmacy or other relevant science or an equivalent combination of education and experience required
- Practical experience of at least 8 years in a QA environment in the pharmaceutical industry required
- Practical clinical manufacturing/packaging/labeling environment experience required
- Practical experience with manufacturing of solid dose pharmaceutical products required
- Experience auditing clinical solid dose manufacturing, packaging, and labeling contractors required
- Good understanding of GMPs within a global environment required
- Good understanding of method development and validation, specification setting preferred
- Communicate effectively with contractors for technical information
- Good technical and QA background having a good understanding of drug product development.
- Disposition certify and release IMP as required ensuring compliance
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.