debojyoti adak

Quest Nutra - Regulatory Affairs Manager, QPPV

Validation, Certificate of Analysis, Specifications, Stability data and
report, Bioequivalence, etc. as per guideline
• Supporting the customers with their required documents on time
• Maintaining an informed awareness of regulatory guidelines and
constant updating of information to new guidelines
• Identifying labeling issues as errors, inconsistencies, conflicts, etc.,
between package leaflet text statements and SmPC and acting
decisively to solve such issues
• Co-ordinating with QPPV to Establish & maintain the
Pharmacovigilance system in QNP
• Preparation of post-meeting files including Quality Control file and
Stability file
• Preparation of the file for the registration of general sales products
• Monitoring the progress of all registration submissions