I am a Quality Assurance/Quality Control Professional with 14+ years of experience in Healthcare, Pharmaceutical, Clinical research and Medical Device, Software industries with exposure to 10+ regulatory inspections from FDA, EMA, ANVISA, TGA, DCGI, CAP and NABL and 180+ audits, from Sponsor, Pharmacovigilance, Internal, External, Third party and corporate audits with compliance to ISO 9001:2008, 15189:2008, 13485:2003 and 17025, GxP, 21 CFR part 11, ISMS (ISO 27001), HIPAA compliance and various regulatory guidelines. Expertise in Quality System development to comply with relevant medical device regulations specifically ISO 13485:2003, FDA 21 CFR Section 820 & EC Medical Device Directive 93/42/EEC, Experience in validation of bio-analytical instruments and usage of LIMS, LDMS, Oracle Clinical, Argus and MedDRA software, Expertise in implementation of Quality Management System by implementing document and Change control, deviation management, Excellent knowledge about validation procedures, preparation and review of Protocols, ICD, IB, CRS and SOPs Completed External Auditor course from (CAP) Collage of American Pathologist, USA. Can work and supervise in all areas of Clinical Research industry and CAP & NABL accredited diagnostic laboratories. Proven leadership skills involving, managing, developing and motivating teams to achieve their objectives, dedicated to maintaining high quality standards. Able to work on own initiative and as part of a team.