Sharma Pokkuluri
Principal Consultant @Elixir Medicals Limited
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WORK HISTORY
Principal Consultant @Elixir Medicals Limited
London, GB
EDUCATION
Osmania University
ADBi, Bioinformatics
Osmania University
BSc, Microbiology, Genetics and Chemistry
University of East London
Master of Science - MS, Biomedical Sciences
Kelmac Group Ltd.
ISO 13485 Lead Auditor Training Course | IRCA Certified, Management Sciences and Quantitative Methods, ISO13485, ISO9001, ISO19011, ISO17021, Auditing
Kelmac Group Ltd.
Internal QMS Auditor, ISO13485, ISO9001, Corporate Auditing
University of Reading
Doctor of Philosophy - PhD, Biomedical/Medical Engineering
Osmania University
MSc, Genetics - specialisation in Genome instability and toxicology
SKILLS
ABOUT SHARMA POKKULURI
Accomplished, analytical, and highly organised QMS auditor and Regulatory affairs Management professional with over 8 years of frontline experience successfully overseeing the drug pipeline and legal compliance of a leading CRO and ensuring stringent quality standards across diverse pharmaceutical research and market analysis. Possess extensive knowledge of FDA, MHLW, CDSCO and EMEA regulations and broad experience with International standards ISO13485, ISO14155, ISO10993 and ISO17025 quality compliance. Demonstrated ability to organise and optimise workflow supported by extensive experience maintaining and updating Standard Operative Procedures. Leverage strong ability to proactively identify issues and orchestrate corrective measures and solutions. Open to learn further in regulatory, quality assurance and clinical trials arena. Available within a week due to contract terms as temporary employment aroused because of circumstances due to an increased workload.Specialties: Analytical laboratory expertise, Regulatory Affairs Management, Quality Assurance - CMC, Team & Workflow Management Scheduling, Data Analysis, DMF/DHF/RMF/FMEA, SOP/MFR/BMR/BPR, FDA & EMEA Standards, Compliance with Medicinal Products and Devices 21 CFR part 807, 812, 814, 820 and ISO-14155, ISO-13485, ISO-10993 & ISO-17025, IEC-60601-1 Compliance with Quality Systems ISO-9001, Compliance with ICH-GCP Practices, CAPA Reporting in QA
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