Vijay Jaiswal

Quality Operations Professional with PG in Microbiology having 20 years of progressive work experience with global/regional/on-site/plant level of involvement in fields of Quality, Functions and Manufacturing Operations of Medical devices and Biopharmaceuticals (Vaccines and Biologicals) with exposure of GMP, GxP, ISO regulated environment. Expertise in Global Quality functions and Manufacturing Operations. Led projects on facility set up, operational excellence with QMS implementation i.e. Technology Transfer/Batch Scale-up/Process Development/Optimization, Green fields/Brown fields projects, Qualifications and Validations, Trainings, Supplier Qualification, Audits and Compliance with results in productivity while achieving Quality culture building and continuous improvement with in the organization. Keen reviewer and thorough investigator with auditing skills as a certified ISO lead auditor.

• Approved Manufacturing Chemist (for Vaccine Manufacturing) By State Drug Controller Authority- Baddi (H.P)
• Certified Internal Auditor for ISO:13485:2012- from DNV, New Delhi
• Certified Lead Auditor for ISO: 13485:2016- from BSI.
• Approved Competent person (for Manufacturing of Medical Devices-QA) By State Drug Controller Authority- Panchkula (Haryana)