Vincent Cuming
Quality Assurance Officer @Nxera Pharma
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WORK HISTORY
Quality Assurance Officer @Nxera Pharma
Nxera Pharma is a technology-powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.Currently working as a Quality Assurance Officer, working within the Global Technical Operations group. I\'m responsible for the maintenance and management of the UK Quality Management System (QMS), supporting Translational Medicine teams in the conduct of Nxera Clinical Trials.RESSPONSIBILITIES AND ACHEIVEMENTS- Company Archivist (management of regulatory archive)- Maintenance and Management of the UK Quality Management System (QMS) at Nxera Pharma- Promoting understanding of, and compliance, with the UK QMS (This includes provision of training, mentoring and informal guidance)- Working with stakeholders to define processes and quality standards and promote continuous improvement- Provision of support to projects and clinical study teams, including review of documentation- Planning and conducting of audits of suppliers, internal systems/processes, investigator sites and study documentation- Completed GCP Archiving external course for the role of the Archivist- Completed ICH / GCP adapted for UK course - certificated- Completed External Auditing Training via the RQA- RQA Membership- Successful rebuild of the UK QMS- Successful implementation of electronic documentation management system - SPOC for the UK site
EDUCATION
St. Marks West Essex Catholic School - Sixth Form
Media Studies
Harlow College
AAT Foundation Level, Accounting
SKILLS
ABOUT VINCENT CUMING
Motivated, enthusiastic individual with over 17 years\' experience within the Pharma industry, from analytical laboratory work to quality assurance, from big Pharma, CROs and Biotechs. Always strive for progression and to perform the best in everything I do.Background in Quality Control and Quality Assurance from Manufacturing, Regulatory, Pharmacovigilance and Clinical.
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