QA Manager

An exciting opportunity has arisen to join a specialty pharmaceutical company's Cambridge office as a QA Manager. The organisation specialises in developing and commercialising innovative drugs to be used in out-patient and hospital-based sedation, anaesthesia, and critical care services. This position is an exciting opportunity to bring expertise and skill to a highly prestigious organisation and bolster a career in the QA field.

Job Responsibilities:

• Provide QA support to all other departments within the company.
• Assist in the maintenance and management of the company's QMS.
• Batch review for API, bulk and packed/labelled material and co-ordination and control of certification/release process together with QPs.
• Write/review/approve internal Quality documents/records (deviations, CAPAs, Change control, SOPs, complaints).
• Conduct Self-Inspections/internal and site audits.
• Conduct supplier/vendor approval via different assessment methods including site audits.
• Support QA team in maintain and manage 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.
• Prepare for any GxP inspection or Due Diligence by regulatory authorities and Licensees.
• Support/host GxP inspection or Due Diligence by regulatory authorities and Licensees at both Cambridge and Aachen sites.

Skills and Requirements:

• Bachelors honours degree
• Professional/industry experience: 0 - 5 years working within Quality in the Pharmaceutical and/or Research and development industries
• Relevant skills and knowledge: o Supplier/vendor approval, including site auditing o Batch review
• Practical use of EUDRA/FDA/ICH guidelines and regulations o Performing Self-Inspections
• Deviation/CAPA writing, investigation, and approval

• Change Control writing and approval/closure.
• Document Control.
• Artwork/Labelling o QC - including review/approval of; release testing, 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.

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 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.

Proclinical Staffing is an equal opportunity employer.

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