Sushmeet Singh

Background

About Sushmeet Singh

Pharmaceutical professional with over 20 years of experience in analytical laboratory operations, product support, and project management. Strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risks. Knowledge and experience with cGMP, FDA, ICH, compendia (USP, JP, EP etc.) and DEA regulations. Experience in innovative analytical method development and testing of parenteral, solid orals, liquid orals, ophthalmic, and specialty dosage formulations. Experience in development, execution, and implementation of laboratory Quality Management Systems (QMS). Analytical Laboratory Experience: • Analytical laboratory procedures (SOPs), processes, and all aspects of laboratory operations • Analytical method developments, validations, and transfers • Analytical laboratory testing schedules and samples tracking • Stability protocol preparation, stability testing, stability data review, expiration/shelf-life dating evaluation and stability program management • Inspection readiness, GMP, Good Documentation Practices (GDP), Data Integrity (DI), and data governance training • Change controls and risk assessments • Quality escalations and Quality Management Reviews (QMR) • Instrument/equipment qualifications, computer systems validation, commissioning, calibration, preventive maintenance, and decommissioning program management • Out of Specification (OOS), Out of Trend (OOT), non-conformance and deviation investigations • Identification of Corrective and Preventive Actions (CAPAs)and quality improvements • Analysts training curricula and qualifications Instrumentation Experience: • UPLCs/HPLC, GC, GCMS, LCMS, ICPMS, Malvern Particle Sizer, Spray View, Spray Tech, Dissolution USP IV, IR, UV, Raman, pH meter, autopipettes, and osmometer Product Submission/FDA Experience: • CMC data package preparation and review. Resolution and preparation of CMC deficiency responses • FDA GMP/PAI Audits and FDA observations remediation plan Computer Systems and Software Experience: • Veeva Vault, Track-wise, Iso-train, Compliance Wire LMS, Qumas, Totalchrome, Chemstation, Empower, Blue Mountain RAM, and Microsoft Office