Sr. QA Specialist (Quality Systems)

Proclinical has teamed up with a market leading biotech know for is Scientific and operational excellence which discovers, invents, develops and manufactures medicines that treat serious medical conditions. They are an established company who have a global presence but are growing rapidly due to a healthy pipeline of new medicines.

The Senior Quality Systems Specialist is a evident quality leader who improves Quality systems and coaches/facilitates employers in executing elements of the Deviation Management System (DMS). The main objectives of this role are to monitor and elevate indicators of trends and emerging Quality trends, to coach and align quality reviewers on consistent application of quality standards and to lead continuous improvement initiatives for process optimization and quality improvement. This position will focus on Deviation, CAPA Management and inter-related elements of the Quality Management System.

Skills and Requirements:

• Authoring and/or reviewing investigation reports.
• Authoring and /or revising SOPs.
• Identifies recurring events and ensures appropriate actions are taken, such as Management notification and trend investigation.
• Keeps QA team members informed of the status of change initiatives and manages implementation of changes throughout the IOPS organization.
• Assists as needed in audits and inspections.
• Other activities associated with tracking of projects, deviations, change controls, etc. as assigned.
• Comprehension of quality and cGMP principles, Quality Management Systems, and relevant Global regulatory guidelines. (quality)
• Experience in performing investigations.
• Experience in application of statistics to quality systems.
• Excellent written, oral, and interpersonal communication skills.
• Excellent time and project management skills with the ability to manage several tasks simultaneously.
• Ability to resolve conflict with tact and diplomacy.

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 call Joseph Emmott on +44 203 8141 316 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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