Quality System Coordinator, External Manufacturing
ProClinical is advertising a vacancy for a Quality System Coordinator, External Manufacturing position with a leading biopharmaceutical company which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in Slough, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
- Carry out the follow-up of the action plans associated with the audits of suppliers and subcontractors.
- Update the quality indicators (KPI) to monitor the quality performance of the various subcontractors and suppliers.
- Maintain up-to-date list of approved suppliers and subcontractors.
- Maintain oversight / delivery of the Quality Management System
- Propose an update of the risk index associated with the various subcontractors and suppliers to update the vendor risk mapping.
- Conduct a generation and analysis of the periodic quality reviews (APR) sent by suppliers and subcontractors in accordance with the procedures in place.
- Complete the control charts and indicators associated with monitoring the quality of the outsourced products.
- Produce PQR summary documents for review by the QA Manager.
- Implement all the activities related to the handling of complaints & Deviations in accordance with the applicable company procedures including:
- Receipt and Analysis from subsidiaries
- Coordination of investigations with subcontractors and approve their conclusion
- Approve the proposed action plans to address the root cause (s)
- Monitor the effectiveness of the proposed actions.
- Implement activities relating to the establishment and updating of the technical documentation including Specifications and SOPs.
- Provide monitoring of the performance of the Quality Management System.
- Implement the Operational QMS.
- Responsible for the maintenance and updating Key Performance Indicators.
- Responsible for the generation of the Quality Management Review.
- Responsible for the maintenance of the departmental training files
- "Own" the TrackWise System on behalf of EMO.
Skills and Requirements:
- A degree in Pharmacy, Chemistry, Microbiology, or Engineering.
- Experience of 'other' industry quality systems/standards, e.g. ICHQ10, ISO 9000.
- Experienced GxP Auditor, Experience in process Improvement.
- Experience of working with/in a CMO. Ideally, this experience should be at least 3 years.
- Minimum of 3 year pharmaceutical Quality experience.
- Demonstrable project management skills.
- 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.
#LI - SF1
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