With a Post Graduate Diploma in Pharmaceutical Studies at the University of Brighton, and with over 15 years experience gained from both commercial and clinical sectors of the pharmaceutical industry in a range of quality disciplines, Michael is currently working as a EU Qualified Person (QP) within an Operational Quality role at a Solid Dose contract manufacturing
With a Post Graduate Diploma in Pharmaceutical Studies at the University of Brighton, and with over 15 years experience gained from both commercial and clinical sectors of the pharmaceutical industry in a range of quality disciplines, Michael is currently working as a EU Qualified Person (QP) within an Operational Quality role at a Solid Dose contract manufacturing facility in the South East of England.
As an EU Qualified Person (QP) under the permanent provisions of EU Directive 2001/83/EC, 2001/82/EC and 2001/20/EC following successful completion of the viva December 2011 Michael has operated as a Qualified Person in releasing commercial solid dose medicinal products to market and also in releasing IMP and comparator products for Phase I-III clinical trials. The latter has included not only solid dose, but also sterile and biotech dosage forms.
Prior to joining his current employer in 2013, Michael worked as a QP at Fisher Clinical Services in the UK. Prior to this, Michael worked at Teva Pharmaceuticals for 10 years initially working within the QC department, leading to a management role within the department and finally working within the QA department in a role that involved the design, implementation and on-going maintenance of CAPA, Change Control and Deviation systems as part of Global QMS activities.
Qualified Person/QA Manager (Operations) @ Primary Functions:
1. To lead the QA Operations Team within the manufacturing facility, working with Operations and Manufacturing to achieve RFT quality and improved GMP standards.
2. To review operational compliance and perform QP release, as appropriate, of satisfactory materials and products to meet production and market needs, respectively.
• Responsible for the management of both the Batch Release and the Deviation processes
• Liaise closely with Manufacturing and Packing operations teams to meet the required GMP and Quality standards.
• Support the review and authorisation of Finished Product Specifications and Raw Materials for pharmaceutical products ensuring compliance with the monographs and the licence.
• Contribute to the resolution of GMP issues within the organisation through identification of problem areas and training of relevant personnel.
• Provide pro-active support and to initiate quality improvements within all relevant areas of the Organisation.
• Provide technical assistance for new product introduction and technical transfer of pharmaceutical products.
• Support the Product Quality review of all pharmaceutical products that Custom are responsible for release to market.
Key Achievements to date:
1) Successful transition of QA (Operations) Team into the Manufacturing Area - resulting in improvements to issue resolution timelines and building of Quality Culture within the production area.
2) Complete revision of Laboratory OOS procedures to meet regulatory expectations which resulted in no observations or deficiencies being noted during recent MHRA inspection.
3) Successful deployment of revised Non Conformance process incorporating risk management principles and root cause analysis techniques following site wide training. From September 2013 to Present (2 years 3 months) EU Qualified Person @ • Acting as an IMP Qualified Person on the company MIA(IMP) licence
• Provide QP certification in compliance with regulatory requirements under EU Directives 2001/83 and 2001/20.
• Preparation and signing of QP GMP declarations, including on site audits as required, in support of importation activities within the Quality Supply Chain.
• Act as Quality Lead, the primary contact for Quality related issues, for a specific client.
• Review and approval of Problem Reports (Deviations) within TrackWise system. From October 2012 to September 2013 (1 year) QA Manager/EU Qualified Person @ • Eligible to act as a Qualified Person in accordance with Article 49 of EU Directive 2001/83EC (as amended).
• Responsible for the release of commercial Solid Dose medicinal product to the UK market.
• Took an active role in site wide deviations/investigations and Change Control activities by acting as both reviewer and approver for these activities.
• Acted as Quality Assurance reviewer and approver of site wide Standard Operating Procedures. From December 2011 to October 2012 (11 months) Quality Systems Officer/Trainee QP @ • Initiated, monitored and reviewed Change Control requests across the site.
• Wrote, reviewed and coordinated the execution of site wide investigation reports.
• Supplied weekly, monthly and quarterly quality systems metrics for both local and corporate management review.
• Prepared and maintained Site Master Files.
• Coordination and preparation activities for both customer and regulatory inspections playing a pivotal role during audit periods.
• Drafted, reviewed and act as a point of contact to assist in the creation/update of site wide Standard Operating Procedures and policies.
• Primary lead for the training of all Quality Management System aspects across the site.
• QA Lead in company Change Control forum ensuring site compliance is maintained during change management process.
• Designed and implemented a new OOS procedure for the analytical laboratories in line with FDA Guidance for Industry document.
• Designed and implemented a new Manufacturing Deviation Reporting process for Teva UK packaging activities.
• Design, set up and implementation of the Internal Audit program. Taking the audit completion rate from 54% 2010 to 100% 2011.
• Design, set up, implementation and management of CAPA process as part of European Corporate TrackWise implementation project.
• Completed the University of Brighton PgDip Industrial Pharmaceutical Studies in conjunction with QP training program. From 2007 to December 2011 (4 years) Deputy Team Leader - Product Analysis Group @ Main role was in the QC approval activities of finished product/intermediate solid dose products. Assisted in trouble shooting activities regarding HPLC apparatus along with the management of 15 Quality Control analysts.
• Liaise with planning and QA departments to allocate workloads to analysts’ according to packaging/UK market requirements and co-ordinate with TEVA affiliate business subsidiaries to allocate workloads in accordance with European market demands.
• Responsible for the upkeep of instrumental calibrations/folders in accordance with GLP and internal SOP policies.
• Troubleshoot analysts’ analysis and overcome instrumental issues.
• Audit analysts’ analytical work, ensuring that analytical methodology and Finished Product Specifications are adhered to correctly culminating with the timely release of products from the QC laboratory
• Reviewing HPLC analysis using Waters Empower data acquisition software and general review of analytical documentation.
• Prepared Change Control documentation as part of the GMP procedure in lieu of changes to analytical instrumentation.
• Organised external training courses for analysts in liaison with external course providers and also arranged inter-departmental tours of the packaging facility in Eastbourne. From 2004 to 2007 (3 years) Stability Analyst @ • Involved in the stability testing of solid dose formulations using predominantly HP 1100 chromatography instrumentation, for the determination of drug efficacy, and degradation products over defined time points/conditions as laid down by ICH guidelines. Hence has a sound appreciation for the necessity of stability testing and its essential need in the pharmaceutical environment.
• Competent in the use of Microsoft computer packages e.g. word and excel spreadsheets for the clear and concise presentation of information and results.
• Drafted and originated equipment IQ/OQ/PQ and validation protocols - consequently involved in the validation procedure of new HP1100 HPLC systems.
• Trained new analysts in the department and produced a PowerPoint presentation as part of the training process and maintained training records in line with GLP/GMP requirements. From 2003 to 2004 (1 year) Senior Laboratory Analyst @ • Performed analysis of generic pharmaceutical products for release to the market place to an accurate and professional standard using product specifications and developed methodology.
• Adhere to GLP/cGMP stringent guidelines in the analysis of such products maintaining current quality systems and followed precise test procedures as laid down in internal SOP’S.
• Work to strict deadlines, thus enabling smooth flow of products through the laboratory.
• Assist fellow colleagues in their workload, consequently contributing to the efficient running of the QC laboratory.
• Confident in the use of HP 1100 chromatography instrumentation, coupled with HP Chem Station data acquisition software.
• Proficient in the use of single point and flow through dissolution apparatus and associated computer packages to gain a portrayal of drug release.
• UV/Vis Spectroscopy and FTIR.
• Karl Fischer moisture determination on Metlor Toledo instrumentation. From 2002 to 2003 (1 year)
PgDip, Industrial Pharmaceutical Science with Distinction @ University of Brighton From 2008 to 2010 BSc (Hons) Applied and Analytical Chemistry, 2.1 @ Staffordshire University From 1997 to 2000 Imberhorne Comprehensive School Michael Clevett is skilled in: GMP, Validation, CAPA, GLP, Change Control, Quality Assurance, Quality Control, Pharmaceutical Industry, Pharmaceutics, Clinical Trials, Pharmaceutical Packaging, Quality Systems, Analytical Chemistry, Pharmaceutical Manufacturing, Tablet Compression
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