ProClinical is currently seeking a QA Contractor GMP for a large academic organisation based in London, UK. This role will be a contract position.
- To support Quality Assurance in efficient functioning and implementation of all Quality plans at site.
- Operational execution of key elements of the Quality System, including document control, quality training, change control, Deviations, CAPA and Customer complaints, to maintain compliance with GMP standards.
- Writing, reviewing, distributing and filing/archiving of completed Quality System documents.
- Investigating Deviations, Change Control, self-inspections, CAPA processes and batch recall.
- Supporting batch documentation (BMR/BPR/GPS) for product release.
- Sampling of Materials
- Supplier assessment and approval.
Skills and Requirements:
- Experience with Q-Pulse ideal
- Graduate, or equivalent, with experience of cGMP and working within a Quality management system environments.
- Two years + experience within QA in the Pharmaceutical industry.
- Demonstrate knowledge and understanding of current regulatory requirements for manufacture licensed medicinal products. Good understating of GMP and GDP and relevant guidelines/updates.
- Knowledge of EU and UK quality related pharmaceutical regulations.
- Experience with Document Control, Deviations, Change Control and CAPA processes.
- Good interpersonal skills and ability to work well within the organisation.
- Experienced in maintaining quality systems, review data, and monitor data trends.
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.