Skill set (11)
Industry fields of expertise
Visweswara Sharma in a few words
Accomplished, analytical, and highly organised QMS auditor and Regulatory Affairs management professional with over 20+ years of frontline experience successfully overseeing the product development, manufacture, compliance, pre-market and post-market support ensuring stringent adherence to consecutive applicable regulations and quality standards across diverse range of medical devices, invitro diagnostics devices, drug-device combination products, OTC and POM formulations with performing high grade research and market analysis. Possess extensive knowledge and on-hands experience handling regulatory submissions to various world markets, broad experience of implementing international standards for quality management complying to the market regulations. Demonstrated ability to organise, optimise - workflow supported by extensive experience, maintaining, updating quality management system from policy level to process controls and implementation of metrics to give foundation to Organisation’s KPI / objectives. Leverage strong ability to proactively identify issues and orchestrate corrective measures and solutions with efficient time management for business needs. Proactive and open minded to learn further in product design and development, regulatory, quality assurance, clinical trials arena and various business strategic and aspire to handled senior management portfolio specialising in life science industry.
Experience
- ELIXIR MEDICALSPrincipal ConsultantCONSULTING & AUDITSAugust 2017 - Today (7 years and 8 months)London, UKBUSINESS OPERATION: Clientele Business management of clinical evaluations and investigation, Quality and regulatory compliance (PQMS, Q9-Risk Management, ISO9001, ISO13485, MDD/MDR, IVDD, OBL/VM and other, Elixir manages client clinical trial, quality assurance and regulatory compliance associated business management activities for medical device, biotechnology, speciality CROs', pharmaceuticals and other life science industries.)PRODUCT PORTFOLIO: Active, non-active medical devices, range of custom client quality assurance activities' (as per request, including but not limited to CAPA, IA, MR, CC and other), regulatory activities' – regulatory submissions – as managing MDSAP audits (including grade 1 to 5 NC communications) with all 5 territories, management of regulatory information to product and process certifications, and senior management.Principal consultant – Rolling Contract as per end clientManaging client audits with their notified bodies or other regulatory agencies against the ISO certifications they sought (ISO 9001:2015, ISO 13485:2003/2012, ISO 13485:2016, MDD/MDR, IVDD, PQMS and market requirements – PMDA, QSR,Sharma Pokkuluri MRSC, MRSB, MTOPRA, MSc (BioMed.Sci), MSc (Genetics)
- PPLUS LTDSME / Senior ConsultantFebruary 2020 - October 2022 (2 years and 8 months)Provision of expertise on implementation of the QMS compliant to ISO 13485, designing process interactions as per the organisations operations and supporting product design and development through design engineering on Plasma-Rich Platelet technologies from start up to pilot scaling from University of Southampton. Responsibilities include reviewing design control documents including DHF, DMR and Technical files as part of DA responsibility.
- Oxoid Ltd, Thermo Fisher ScientificSenior RA ConsultantJune 2020 - March 2021 (9 months)Support regulatory submissions from Market Access team to the needs of the liaison with the regulatory agency and/or authority sourcing and providing product technical documentation with relevant internal stakeholders and manufacturing entities (Oxoid, Remel and Trek), organizing and structuring product documentation for market registration, facilitating the registration parties with product technical documentation and processes of legalization (apostillation and other) for marketing authorization in the respective market, building market performance trend studies (PMPF) for the product portfolio for transfer to Remel Dartford with RUO, LUO, IVD and other medical devices.
Recommendations
Education
- Doctor of philosophyUniversity of ReadingResearch in School of Biomedical Science on use of microfluidics in thrombosis disorders for cardiovascular diseases
- Master of ScienceUniversity of East London2008Biomedical Science with 2 research project dissertations on 1. Superantigen-induced deregulation of regulatory T-cell function on effector T-cell signaling - Under the supervision of Dr. Nadia Terrazzini and Dr. John Wright, University of East London 2. Differential Screening of virulent and non-virulent strains of Clostridium difficile defining the molecular basis for virulence in strains causing nosocomial infections - Under the supervision of Dr. Sally Jane Cutler, University of East London
- Advanced Diploma in BioinformaticsOsmania University-PGRRCDE2003Bioinformatics with crystallographic theoretical model deposition in Brookhaven Protein Databank (RCSB) 1. Comparative modeling of N5, N10-Methenyl Tetrahydromethanopterin Cyclohydrolase from archaeon Methanobacterium thermoautotrophicum Δ‘H’ strain - Under the supervision of Dr. Naga Raja Ram and Dr. Nunna Siva Kumari at CDFD 2. Structure deposition of theoretical models 2IOZ.pdb and 2IR7.pdb at the Research Collaboratory for Structural Bioinformatics (RCSB PDB)
- Master of ScienceOsmania University2002Genetics with Toxicology, immunochemistry, molecular biology and genome instability specialisations
- Bachelor of ScienceOsmania University2000Microbiology, Genetics and Chemistry
Certifications
- Lead Auditor-Quality Management Systems ISO13485Kelmac Group (under the IRCA accreditation)2015