Rajesh Bathini

WORK HISTORY

EDUCATION

SKILLS

ABOUT RAJESH BATHINI

Results-driven professional with a strong and robust skill set in Quality Assurance and regulatory compliance in pharmaceutical formulations.• Hands of experience in Quality Assurance activities analytical data review, Investigations, CAPAs, SOP design, Specifications design, Change controls, Stability management, Batch release, self inspections, vendor audits, Regulatory & customer audit support and regulatory support for ANDA registration and filing requirements.• Having experience in USFDA, MHRA and other regulatory audits.• Strong understanding of regulatory requirements to compliance data integrity.• Well exposure of cGMP systems, regulatory requirements and impact assessment.• Sound exposure in stability studies and data management activities.• Good exposure in computer system validation, EU part 11 gap assessments and audit trail review.• Well utilized LIMS, DMS, LMS and SAP systems to streamline data analysis, document management and operational processes.• Provided GMP Trainings to the staff, enhancing, understanding and adherence to regulatory requirements.• Instrumental in decision making to meet the deliveries without compromise compliance.• An effective communicator and negotiator with strong problem solving skills.