director quality gmp and gdp@ WORLDWIDE CLINICAL TRIALS EARLY PHASE SERVICES
Gravesend, England, United Kingdom
Olufemi Lakeru
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University of Greenwich
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FlashIntel GPTOlufemi Lakeru is an experienced EU Qualified Person (QP) and Quality Assurance Manager with over twenty years of experience in the pharmaceutical industry. She has a strong technical background and extensive working knowledge of the EU and US Good Manufacturing Practice (GMP), as well as the development and implementation of effective Quality Management Systems (QMS). Olufemi has expertise in developing and implementing commercial and clinical medicinal products and GMP outsourcing activities. She has held various leadership positions in reputable companies such as WORLDWIDE CLINICAL TRIALS EARLY PHASE SERVICES, Evelo Biosciences, GW Pharmaceuticals plc, GSK, and GE Healthcare.
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About
EU Qualified Person (QP) and Quality Assurance Manager, with over twenty years experience in pharmaceutical drug product development, clinical trials and commercial drug product manufacture. Strong technical background and in-depth working knowledge of EU and US Good Manufacturing Practice (GMP), development and implementation of effective Quality Management System (QMS),QP disposition of commercial and clinical medicinal products and GMP outsourcing activities.Specialties: EU Qualified Person (QP) via the permanent provisionInvestigational Medicinal Product (IMP) Marketed ProductsSolid and Liquid/Sterile Injectable Dosage formsEarly/late phase clinical studies including radiopharmacy, PET, compounding, etc.Quality Risk ManagementQuality compliance/Quality Management System (QMS)Contractor and Supplier Lead AuditorCMO Oversight ManagementGMP TrainingRegulatory inspection hosting Key Quality Performance Indicators (KPI) and Process Improvement
...See MoreWork Experience
director quality gmp and gdp
Hospitals and Health Care
Olufemi Lakeru's Professional Milestones
- Quality Specialist | Drug Product Manufacturer (2004-03-01~2010-09-01): Implemented efficient quality control measures to ensure product compliance and exceed customer expectations.
- Head Of Commercial Quality Assurance Qualified Person (2020-02-01~): Implementing comprehensive quality assurance policies and procedures for industry-leading products, ensuring compliance and client satisfaction.
Education
Industrial Pharmaceutical Studies,
Pharmaceutical Sciences
2002-2004Skill
Pharmaceutical Industry
Quality System
Quality Assurance
Sop
Validation
Glp
Fda
Regulatory Requirements
Regulatory Affairs
Certification
Colleagues
Mary M. Alexander
consultative sales | sales strategy | partnership management | relationship building | cro | clinical trial solutions | digital transformation | driving adoption | growing revenue
Silvia Gutierrez
Senior Clinical Trial Manager | CTM En WCT
David Kirker
paramedic at cedra clinical research
Other Named Olufemi Lakeru
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Olufemi Lakeru works for WORLDWIDE CLINICAL TRIALS EARLY PHASE SERVICES
Olufemi Lakeru's role in WORLDWIDE CLINICAL TRIALS EARLY PHASE SERVICES is director quality gmp and gdp
Olufemi Lakeru works in the industry of Hospitals and Health Care
Olufemi Lakeru's colleagues are Mary M. Alexander,Silvia Gutierrez,David Kirker
Olufemi Lakeru's latest job experience is director quality gmp and gdp at WORLDWIDE CLINICAL TRIALS EARLY PHASE SERVICES
Olufemi Lakeru's latest education in University of Greenwich
