QA Associate GMP

Proclinical is seeking a QA Associate (GMP) to join a pharmaceutical company that develops out-patient, anesthesia and critical care services. This is a permanent position based in Cambridge, UK.

Job Responsibilities:

• QA support to all other departments within the company
• Assist in the maintenance and management of Company's QMS
• Batch review for API, bulk and packed/labelled material and co-ordination and control of certification/release process together with QPs
• Writing/review/approval of internal Quality documents/records (deviations, CAPAs, Change control, SOPs, complaints)
• Conducting Self-Inspections/internal and site audits
• Conducting supplier/vendor approval via different assessment methods including site audits
• Support QA team in maintain and managing Company's Quality and Technical agreements including writing, review and approval
• Support QA team in monitoring and management of all QA aspects of contract manufacturing organisation (CMO) and contract laboratories with regards to API, bulk and packaging
• QA review and approval of external documentation and records (deviations, Change Controls, specifications, master batch records QC methods, validation protocols and reports, FMEA etc)
• QA support for licensees

Education, Skills and Experience:

• Bachelors honours degree
• Professional/industry experience: 0 - 3 years working within Quality in the Pharmaceutical and/or Research and development industries
• Relevant skills and knowledge: Supplier/vendor approval, including site auditing o 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
• Artwork/Labelling
• QC - including review/approval of; release testing, method validation
• Knowledge of Manufacturing Processes

To Apply:

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 Katty Maia at k.maia@Proclinical.com 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.