Manjit Kumar Email & Phone Number

Assistant Manager (Drugs Substances Lead) in Quality Assurance with over eleven years of experience in Drugs Substances Manufacturing process in Bio-pharmaceutical (Biologicals and Mammalians) and Pharmaceuticals industries. Develop, supervise, and evaluate Quality assurance techniques utilized to deliver quality in accordance with cGMP and regulatory requirements in order to contribute to the attainment of business/function objectives. Lean six sigma certified, Knowledge of quality management systems, Quality Risk Management, auditing, and assistance with the creation, integration, and application of QMS. Managing all QA activities and requirements, as well as interpreting user issues and recommending suitable system modification suggestions to address flaws and improve system performance. Taken a proactive role in the administration of regulatory audits, including those conducted by the USFDA, MHRA, EMA, WHO-Geneva, CDSCO, TGA, PMDA, Cofepris, Russia, and customers.

Listed skills include Biotechnology, Life Sciences, Gmp, Pharmaceutical Industry, and 7 others.