QA Manager

A specialty pharmaceutical company is advertising a vacancy for a QA Manager with their office in Cambridge. 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 is an exciting opportunity to work with a leading company and provide real experience in the QA field.

Job Responsibilities:

• 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.
• 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 the 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.
• Prepare the company for any GxP inspection or Due Diligence by regulatory authorities and Licensees.
• Supporting/hosting GxP inspection or Due Diligence by regulatory authorities and Licensees at both Cambridge and Aachen sites.

Skills and Requirements:

• 0 - 5 years working within Quality in the Pharmaceutical and/or Research and development industries.
• Supplier/vendor approval, including site auditing.
• Practical use of EUDRA/FDA/ICH guidelines and regulations.
• 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 Katty Maia at +44 2038543317 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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