Peter Glaubenstein
Quality Consultant @Lumiradx
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WORK HISTORY
Quality Consultant @Lumiradx
Edinburgh, GB
LumiraDX is a global point of care and healthcare provider that provides a portfolio of healthcare technologies, including diagnostics, medical devices. I was engaged to review quality and development lifecycle document suite and to ensure GxP compliance with the introduction of new SW products and platform Assays, including risk management, safety, and cybersecurity. Ensured platform and instrument validation was in accordance with regulations for various components, including URS, UAT, IQ, OQ, PQ, Acted as SME to facilitate delivery of major initiatives, including new SW launches for base platform and getting product ready for 501k submissions. Utilised ‘corrective action preventive action’ (CAPA) to investigate and resolve root cause of IT quality problems, e.g. identified precise cause of potential instrument fault and risk / process mitigations. Produced a wide-range of documentation, including risk reviews, reports and technical guidelines to aid diagnostics. Updated Risk Management Processes / tool to ensure its’ capability to evaluate and identify potential failures related to operational processes, e.g. identified vulnerabilities that may impact on productivity, quality control, and safety.
EDUCATION
University of Wolverhampton
BSC, Chemistry
SKILLS
ABOUT PETER GLAUBENSTEIN
I’m a highly experienced Quality Consultant, well-versed in developing and implementing a quality strategy to ensure the organisation is equipped with the tools and documentation required, while keeping in mind business goals. I achieve success by combining more than 10 years progressive experience gained operating in cutting-edge environments, with a ‘hands on’ approach, to conduct effective performance quality tests and design exceptional remedial quality control programmes.I operate as an independent contractor supplying a technical service to clients; my company is Redkite Technology Projects ltd ©2023, and customers include Abbott Laboratories, Convatec Group, Mölnlycke Health Care, Novacyte Group, and GSK Plc. With contracts I have provided consultancy services on all aspects of quality and assurance, including validation lifecycles, design assurance and controls, good manufacturing practices, software risk assessments, design reviews, gap analysis, data integrity, and regulatory compliance. The exceptional level of client satisfaction is reflected by the high number of repeat contracts offered.My forte is examining QMS and business practices and making them more effective. This attribute was demonstrated as IT Consultant with Abbott Laboratories when, I seized the initiative, and improved and rationalised processes by conducting astute ‘gap analysis’, corrected deficiencies, and instigated training to up-skill employees. The improvements enabled senior managers to make better informed business decisions.Aside from the technical aspects of my role (e.g. UAT, TMV, cybersecurity, A 510k submissions, and verification & validation methods), my effective communication skills instil confidence with stakeholders, senior managers, and colleagues to give transparency, generate synergy, and create an environment of trust, respect, and co-operation.I am currently seeking to leverage my skills to secure a new assignment, if my profile matches your requirements, please contact me for a copy of my CV.Specialities:QA Methodology and Production Management / Compliance - Regulatory and Standards / Training, Coaching, and Mentoring / Risk Management and Mitigation / Site Acceptance Testing, e.g. IQ, OQ and PQ / Developing and Implementing Quality Plans / Project Management and Delivery / Technical Consulting / Testing, e.g. UAT, TMV, and Integration / Regulatory Submissions / Defining Performance Management / Stakeholder Engagement
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