Richard Corbett Hons Acmi

Quality Standards Lead (Biopharmaceutical) Control Test Laboratories @GSK

London, GB
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WORK HISTORY

Jul 2019 — Present

Quality Standards Lead (Biopharmaceutical) Control Test Laboratories @GSK

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Stevenage, GB

Successful Implementation and deployment of Veeva Quality Systems (Quality Site Implementation Manager for Veeva Quality Docs and VeevaQMS).Local Business Administrator and documentation specialist for Veeva VQD & VQMS. Veeva Report, Dashboard & KPI local champion.QMS champion - ensure compliance with all appropriate cGMP, cGLP and GSK Policies and Standard Operating Procedures.QMS implementation - management of gap analysis of procedures against regulatory guidelines, GQPs, Technical standards and GQSOP implementationsAudit process owner – Manage Management Monitoring (L1), IBM program (L2), Audit and Assurance (L3) and Regulatory Audits (L4) – manage follow ups and CAPA process.Inspection Readiness – Manage Areas to ensure in an inspection ready state.QRM owner (Quality Risk Model) – Quarterly review of Quality Management systems against Site performance and standards for compliance. Quality Alerts Management, QRI management (Quality & Regulatory Intelligence) – Review and Impact assess relevance of Alerts to site processes and systems from the central team and RIC team (Regulatory Inspection & Compliance).Quality Council secretary – manage the metrics for the site and facilitate the Quality Council meetings.Quality Assurance role support when required.Quality / Validation approval of documents, procedures & Computer Systems.Ensure GMP training management program is maintained.Accountability for any responsibilities undertaken on behalf of the QA Operations Manager.

EDUCATION

1996 — 1999

Queen Mary University of London

Bachelor of Science (BSc), Biology/Biological Sciences, General

SKILLS

LimsPrince2Aseptic TechniquePersonnel DevelopmentEndotoxinInvestigationsPharmaceutical MicrobiologyComputer System ValidationFood MicrobiologyQuality SystemGreen BeltQuality AssuranceSelf ManagementSterility AssuranceIsolator TechnologyBatch ReleaseProblem Solving21 Cfr Part 11Lean SigmaRisk AssessmentBiopharmaceuticalsDiversityProject ManagementCoaching StaffClinical ResearchCapaInternal AuditQuality ControlGmpValidationProcess ImprovementSopFdaMicrobiologyStaff MentoringTrend AnalysisInterviewingCycle Time ReductionMicrosoft OfficeSterile Manufacture

ABOUT RICHARD CORBETT HONS ACMI

A Quality Assurance professional with over 20 years experience working in the pharmaceutical Industry with expertise in biopharmaceuticals, aseptic manufacturing of sterile and oncology products to GMP / GLP, the quality assurance process and quality management system ISO 9001:2008 standards. I have held management responsibilities, overseen complex investigations leading to crucial quality decisions. I have managed change through project management while decommissioning buildings and equipment, requiring detailed organisation, planning and focus on identifying business priorities. As well as working with complex supply chains. I have successfully led the implementation of a new document management system VQD (Veeva Quality Documents) and VQMS (Veeva QMS module) deployed to site. I have a high work ethic with experience in a number of roles working in the UK and Australia. I have worked as a Credit Finance assistant, in Scientific Research, Food Quality Control and Pharmaceuticals. My experience ranges from team work to team leadership, compliance and project management, where I have learnt to how deal with a range of different personalities through diversity. I have a keen eye for detail, working with large amounts of data to make crucial decisions. I have a sense of responsibility gained from valuable industry experience in a highly regulated area where I thrive under pressure and am results and goal orientated to achieve my own and my teams set targets.

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Richard Corbett Hons Acmi — Quality Standards Lead (Biopharmaceutical) Control Test Laboratories at GSK in London, GB | Unifers