Saurabh Soni

About Saurabh Soni

Result-oriented continuous process improvement team leader with more than 11 years of experience in the pharma, and Life Science industry, quality, and management resulting in efficient, accurate, and cost-effective product quality. Experience working in cross-functional environments to improve QMS. • Experience in IQ, OQ, PQ, Material Qualification, Equipment Testing, Change Control, material qualification, Supply chain, R&D Support, Audit Management, transactions codes, Software validations, and implementation, performance within SAP for material qualification, material qualification report review and approvals, change control impact assessment review and performance, supplier tracking, SCN. • Developed and implemented quality programs, including tracking, analyzing, reporting, and problem-solving. • Experience in Supplier Qualification and maintenance/Quality Agreements, Supplier Decommissioning, CAPA, Field Complaints, Risk Management, Audit, gap analysis, adverse event reporting, PPAP, & Product nonconformities. • Performed and approved supplier specifications and assessment of local suppliers. • Experienced in cGMP, FDA Regulations, Supplier Audit, Supplier Qualification, transfer process, validation, documentation, change control, and overall process improvement. • Experience working with multiple projects, effectively coordinating project activities, communicating progress, collaborating on key deliverables, and completing within timeline and deadlines. • Provide product quality support for external audit and internal audits. Lead and Participated in Material Review Board. • Evaluation of audit observation and findings, audit report, follow-up, and verification of corrective actions. • Provided guidance to team members in the area of supplier audit, material qualification, procurement, supplier change, and corrective action through audit and CAPA processes. • Experienced in deviations, statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOP’s and Change Control.

Experience

1. Sr Scientist

   Cambrex

   Jun 2022 — Present · US

   Perform Method validation/ transfer/verification testing for Analytical development. Write and review method validation protocols, reports, SOPs, and investigation reports. Identifies and quantifies all ingredients in reference formulation to ensure cost effective formulation is achieved. Performs and evaluates study for Pre-formulation of solids, solution, suspension, gels, ointments, cream, and inhaler dosage forms. Transfer new analytical techniques from various clients. Perform routine analytical testing for in-process, release, stability, and method validation/transfer/verification activity. Perform method development utilizing established scientific techniques and automated instrumentation (UPLC, HPLC). Investigation specification, investigation testing and investigation reports. Write technical papers and reports; and prepare standard and specifications for processes, facilities, products, or tests. Support IND, NDA, ANDA filling documents.

Education

• Devi Ahilya Vishwavidyalaya

  Master's degree, Biotechnology, 73 % (GPA-3.8/ 4)

  2003 — 2005

• Devi Ahilya Vishwavidyalaya

  Bachelor's degree, Microbiology, General

  2001 — 2003

• Kendriya Vidyalaya no. 1 indore

  High School Diploma, Physics, Biology and Chemistry., A

  1988 — 2000

• Pittsburg State University

  Master's degree, Chemistry, 3.3 GPA

  2010 — 2013