A speciality pharmaceutical company is seeking to recruit a QA Lead to their office in Cambridge. This organisation develops and commercialises innovative drugs to be used in out-patient and hospital-based sedation, anaesthesia, and critical care services. This vacancy is an exciting opportunity to work with an establishment that is determined to be an acknowledged pioneer in sedation and anaesthesia.
- Providing QA support to all other departments.
- Assisting in the maintenance and management of QMS.
- Performing batch review for API, bulk, packed/labelled material, and co-ordination and control of certification/release process together with QPs.
- Writing/reviewing/approving internal Quality documents/records (deviations, CAPAs, Change control, SOPs, and complaints).
- Conducting Self-Inspections/internal and site audits.
- Conducting supplier/vendor approval via different assessment methods, including site audits.
- Supporting QA team in maintaining and managing Quality and Technical agreements including writing, review, and approval.
- Supporting QA team in monitoring and managing all QA aspects of contract manufacturing organisation (CMO) and contract laboratories with regards to API, bulk, and packaging.
- Performing QA review and approval of external documentation and records (deviations, Change Controls, specifications, master batch records QC methods, validation protocols and reports, FMEA etc).
- Performing QA support for licensees.
- Preparing for any GxP inspection or Due Diligence by regulatory authorities and Licensees.
- Supporting/hosting GxP inspection or Due Diligence by regulatory authorities and Licensees.
Skills and Requirements:
- Bachelors honours degree.
- Up to 3 years working within Quality in the Pharmaceutical and/or Research and development industries.
- Experience with Supplier/vendor approval, including site auditing.
- Batch review.
- Practical use of EUDRA/FDA/ICH guidelines and regulations.
- Performing Self-Inspections.
- Deviation/CAPA writing, investigation, and approval.
- Change Control writing and approval/closure.
- Document Control.
- QC - including review/approval of release testing and method validation.
- Knowledge of Manufacturing Processes.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Steven Fuller at +44 203 854 2630 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.
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