QA Associate GMP job in Cambridge, Cambridgeshire

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Phone Number*

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This vacancy has now expired. Please see similar roles below...

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.

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