Pankaj Shah

About Pankaj Shah

Knowledge about API as well as formulation. Familiar with tablet,capsule,gel,ointment,powder,syrup manufacturing and analysis Conduct QA activities in the laboratory area as per appropriate SOP Batch processing record(BPR ) issuance and release. Praparation of Raw material, intermediate and finished product specification Preparation of Standard testing procedure(STP),Method of analysis(MOA) etc. Handling of deviations, change controls, out of specifications. SOPs preparation and review,carry out internal audit. Handling of investigations like market complaints, OOS, OOT, deviations,CAPA system etc. Familiar with HPLC/HPTLC/UV/GC Analytical method development & Validation Knowledge of QMS,GMP,GLP,ICH guidelines Ensure line clearance surprise check and GMP compliance in all dept. Preparation of stability data. Audit faced: WHO(Formulation), Cadilla Healthcare( Curcumin-95% API)

Experience

1. Sr Executive, Regulatory Affairs

   Ctx Lifesciences

   Apr 2026 — Present · IN

   Regulatory Affairs activity

Education

• April-2011 First

  B.Pharm A

• Sardar Patel University

  B.pharm, PHARMACY

  2006 — 2010

• University 2006-2010 First

  Bachelor of Pharmacy (B.Pharm.), Pharmacy

  2006 — 2010

• M.s.university,Baroda.

  M.Pharm, Herbal Drug Technology

  2010 — 2012

• Tata High school, Navsari

  S.S.C, 2004

  1992 — 2006

• Faculty of tech. & engg

  M.S

Skills

• Glp
• Gmp
• Uv
• Generic Programming
• Pharmaceutical Industry
• Sop
• Pharmaceutical Research
• Validation
• Hplc
• Chromatography
• Anda
• Regulatory Affairs
• Dissolution
• Formulation
• Tlc
• In Vitro
• Method Development