Anupama N.

Background

About Anupama N.

HIGHLIGHTS OF PROFESSIONAL EXPERIENCE Professional, highly focused, scientifically strong, technically proficient, results-driven, patient, problem solver, tri-lingual, energetic, accountable, efficient, strategic thinker, inter-functional coordination, building work relationship, and flexible scientist with more than 15 years of credible experience in Quality, Regulatory compliance, Project planning, Bioanalytical, Analytical, Pharmaceutics, Research, Development, Food and Toxicology areas for small and large molecule Skills: Intensive working experience from the early phase to the commercial products. • Method transfer of Clinical and Commercial Methods • Experience with working CRO and CTL • Method development, qualification and validation/ verification • Hands on experience on various techniques etc. • Comprehensive understanding of cGxP’s (GMP, GLP, GCP) and GAMP guidelines, ICH Q7, ICH Q9, 21 CFR Part 11, and 210, 211, and 820. • Stability including stability protocols and reports • SOP revisions that address compliance deficiencies and gap analysis in systems. • Deviations (including containment, risk and impact assessments, root cause analysis etc.) • Lot selections • Change Controls and QIPs (including feasibility assessments, planning and execution oversight) • Method Performance Investigation. • BLA, IND and NDA Regulatory submissions • APQR filings. • Data trendingegulatory