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.

Follow good laboratory practice and focus for regulators such as WHO, MHRA and USFDA.

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