Bharath R. Email & Phone Number

Highly driven quality professional with excellence in end-to-end Quality and Information security Management with focus on accomplishing organizational goals & objectives in life sciences Sector.• Experienced in reputed pharmaceuticals organizations combining all aspects of In-process quality Assurance, Quality assurance, RA.• I am having responsibility for implementation of quality management system in the entire organization, which includes investigations, deviation, change control, CAPA and risk assessment management.• Hands on Experience in regulatory inspections as USFDA, Health Canada, EU GMP, COFIPRIS.• Experienced in BSI audits on ISO 9001 and 27001. Successfully lead the ISO 27001 certification project and got certified. • Sound Knowledge in GAMP 5, 21 CFR Part 11, EU Annex 11, ICH, ISO 9001 & 27001 standards and requirements to make the system compliance with respect to quality management system.• Lead customer audits and Vendor site auditors.Training credentials:• Certified Internal Auditor (QMS) ISO 9000:2015 • Certified Lead Auditor (ISMS) ISO 27001:2013• 21cfr part 11- Risk Assessment - From Compliance Trainings