Abhishek Kumar Shukla

• Handling of QMS section and Prepared and Reviewed standard operating procedure (SOP) and its implementation.
• Handling of laboratory deviation, change control and CAPA in QMS.
• Preparation of tracker for analyst error, instrument error/communication failure on monthly basis and as & when required for audits and review.
• Performing internal audit of QC laboratory regarding verification logbooks, entry registers, calibration status of instruments.
• Performing monthly audit trial review of standalone system (UV Probe IR spectrum ES, Tiamo 2.5, etc.), Empower CDS (HPLC, GC), LabSolutions (GCMS), MassLynx (LCMS/MS).
• Handling of laboratory deviation, change control and CAPA in QMS.
• Handling of internal and external audits and its compliance.
• Awareness training has bene imparted on Audit trail requirements electronic record, 21CFR PATR 11, ALCOA.
• Follow 21 CFR Part 210- Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs.
• Follow 21 CFR Part 211 Current good manufacturing practice for finished pharmaceuticals.

Over 17 years’ experience in the Pharmaceutical industries managing QC testing for a wide analyzed of product from Tablets, Capsules, Liquid injections, Powder injections, Ointments, Creams, Gels, Syrups and Suspensions. To secure a challenging position in a reputable organization to expand my learnings, knowledge, and skills. Secure a responsible career opportunity to fully utilize my training and skills, while making a significant contribution to the success of the company.

M.Sc. Org. Chemistry