Consultant - R&D,Formulation, GMP,Qualification,Validation,Regulatory- Pharma,Nutraceuticals
Professional Experiences:
-Regulatory Affairs: CTD submissions for MA, Review of dossiers - Specifications, Validations, Stability Studies.
-Project Management: Tracking of activities from Production Perspective and Regulatory pathway. Gap analysis & compliance
-Q.A: Gap analysis & compliance as per cGMP, BMR review & Batch Release. In process Q.A from starting material stage to labeling & packaging & Dispatch, Review of validation docs., Tracking and trend analysis of Stability studies, Failure Investigations, Market complaint handling, Conducting Internal audits, External audit handling. Vendor audits and approval
Expertise in Document Review and Audit handling, formulation and cons...