Santosh P.

About Santosh P.

Over 20 years of diverse and progressive experience in cGMP/ GLP environment within…

Experience

1. Senior Quality Control Analyst

   Teva Pharmaceuticals

   May 2008 — Present · Elizabeth, NJ, US

   Perform analytical test according to the in-house methods, Method Validation Protocols, Method Transfer Protocols, USP monograph and SOP in compliance with cGMP, cGLP and cGDP• Supported technology transfers to internal or external manufacturing sites• Perform analytical testing in support of Finished-products, intermediates, Method Validation Samples, Method Transfer samples, cleaning verification samples based on requirement and stability studies.• Expertise with HPLC analytical techniques for Related Compounds (impurities), Assay, Dissolution, Identification test• Experience with GC analytical techniques for Assays and Residual Solvents• Review and approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as required • Serve as data reviewer of SOPs, work instructions, forms and internal or external analyses.• Experience with additional analytical techniques TOC, UV-VIS, Conductivity• Maintain compliance with applicable ICH, GxP and safety regulations. • Notify management of unexpected results, procedural deviations and equipment problems.• Investigation for critical deviation and OOS results.• Participate in formal laboratory investigations (deviations, Out of specification results) process to find sources of error (root cause) and derived preventive/corrective actions (CAPA).• Maintain a collaborative working relationship with manufacturing/testing partners and other Teva departments.• Lead a compliant laboratory operation in accordance with SOPs, internal procedures and policies• Determining team priorities in accordance with the plant’s needs, while coordinating with the Departmental Manager.• • Implementing quality system with respect to regulatory ICH & cGMP requirement.• Maintaining a set of procedures supporting the quality control system (cGLP and cGMP techniques implementation)• Trained new analysts successfully on HPLC, Dissolution, UV-VIS, Karl Fischer, Fraction Collectors

Education

• Maharshi Dayanand University

  Master's degree, Organic Chemistry

• Maharshi Dayanand University

  Bachelor's degree, Chemistry