DATA INTEGRITY ASSESSMENT ,HEALTH AUTHORITY ENFORCEMENT ACTION AND RESPONSE PREPAREDNESS ,FDA READINEES SUPPORT ,END TO END QUALITY COMPLIANCE REGULATORY CONSULTING ,FDA REMEDIATION ,DATA INTEGRITY ,C

経験内容

Highly energetic, task oriented seasoned pharmaceutical professional consultant with over 15+ years of working experience with several multi-national pharmaceutical and bio pharmaceutical companies including top 5 global pharma companies. Held various Quality roles with Global pharma companies and consultancy involved in Training, Quality and compliance, Validation, managing regulatory inspections and implementing quality systems from both operational and strategic perspective, utilizing process excellence methodologies for audits and global compliance.
Demonstrated expertise in critical Quality and data integrity remediation and Quality System implementation, manufacturing operations, pharmaceutical validation and business process improvement. Supporting management and advisory teams, designing and delivering in the areas of preventative and remediation solutions. Successful in leading and directing cross-functional teams to accomplish critical strategies in compressed frames.
Extensive experience of working as direct personal interface with international regulatory agencies like US FDA, Health Canada, EDQM and WHO Geneva and as an advisory level for TGA, MHRA, ISO, MHLW, Japan. As an consultant personally worked for several Indian customers also indirectly worked with international pharmaceutical companies