Arvind VijayabhaskarArvind has worked in the pharmaceutical industry for over 20 years.  

He has been a Qualified Person since 2011, Chartered Chemist, Chartered Scientist, Industrial Pharmacist and Responsible Person.Arvind’s experience covers manufacturing, process validation and formulation development of tablets, capsules, and MDI inhalers. Proven ability and exposure in manufacturing and quality assurance as a QP, working across product lines such as tablets, capsules, MDI inhalers, ointments, creams, gels, liquid sprays, aerosols, and nasal sprays. Practical work experience in sterile dosage forms for terminally sterilized products and Biosimilars. Gained experience on Biological products, successfully completed the Biological Therapeutics module at University of Oxford.

In 2017 Arvind became an independent consultant and routinely prepares and delivers training programs on the topics related to QP study guide modules and problem-solving scenarios, OOS Investigation, Statistical process control and sampling, QRM tools and Root Cause Analysis techniques, Legislation Impact assessments and quality evaluation/Gap analysis.

As a QP Arvind managed the 13 contract manufacturing sites, 2 testing sites and 2 storage sites based in India, Middle East, and EU countries. He has extensive GxP auditing and inspection experience Act as lead auditor for audit/inspection program for the GMP facility and systems (including automation systems), GDP audits for the supply chain and distributions sites, GCP and Pharmcovigilance internal audits and service providers. Arvind also has Investigational Medicinal Product experience having performed QP release of commercial and IMP sterile medicinal products (Drug Device combination) for the US and Canada markets. Assisted technical writing for protocols, reports, specifications, policies, and procedures and implemented corrective and preventive action (CAPA) programs-including development, execution, monitoring, and project management.

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