Pratik Krishna

About Pratik Krishna

Profile Summary:More than 12 years of rich experience in Quality Control in improving productivity of business and successfully implementing quality systems.>Exposure of audit in US FDA, TGA Australia, ANVISA Brazil, MCC South Africa, CDSCO India, RP Darmstadt Germany, Taiwan FDA, Uganda Regulatory and WHO.>Possess working exposures of API industries, Parenteral (LVP & SVP), Tablets, Capsules, Syrups, Ointments and Lozenges.>Expertise in Lab Compliance, LIMS & SAP management, Analytical data Review, GAP Assessment, Instrument Qualification, Software Qualification, CAPA, Change Control, Deviation, OOS/OOC and Lab incidents.>Deployed various methodologies for analyzing processes,recommending modifications to minimize escalations & rejection for realizing operational efficiencies, and control costs and cycle-time.*My Current Responsibility-1)Section Head : GLP and QC Compliance.2)To Supervise all QC activities as per Regulatory Guidelines and to ensure the QC Compliance adherence.3)To ensure all analytical activities like Qualification, Calibration & GLP should proceed as per scheduled plan.4)Proper Execution of OOS, OOT, Lab incident, Deviations and Change Control through Trackwise software and also give awareness training for avoidance of analytical error or repetitive errors to concerned personnel.*Technical & Documentation Skills -1)Qualification of analytical instrument with software validation as per GAMP 5 Modules, 21 CFR (PART - 11), EDQM (Annex-3) and EU GMP (Annex-11) Compliance.2)Caliber LIMS System Administrator in following companies like Unichem laboratories limited, SIKKIM, Fresenius Kabi Oncology ltd, Kalyani and LIVA PHARMACEUTICAL LIMITED, VADODARA.3)Review and Analysis Experience skills in Raw Materials, Packing Materials, Intermediates, Bulk Finished Products, calibration records and stability samples records.*Certifications -1)Classroom training in Global Labware LIMS program at Fresenius Kabi, Oberursel, Germany.2) Approved Technical Staff by FDA, MAHARASHTRA in Chemical and Instrumentation section in 2018.3) Approved Chemist in Quality Control by Deptt. of Healthcare Human Services & Family Warfare,Sikkim.

Experience

1. Section Head Pharmaceutical Quality Control (Glp, Rm, Csv & Quality Compliance)

   Fresenius Kabi

   Dec 2017 — Present · Pune, IN

   Section Head : Pharmaceutical Quality Control (GLP, RM, CSV & Quality Compliance)*Key Areas Responsibility:>Planning & monitoring of QC Compliance, CSV, Instrument Qualifications, Software Qualifications,GLP activities and Raw materials activities with existing subordinate as per scheduled plan.>Reviewing calibration record sheet and performing Software validation as per GAMP 5.>Executing review of QC instrument software audit trail as per plan.>Resolving analytical troubleshooting after discussing with team.>Conducting GAP analysis as per quality standards & SOP.>Preparing & reviewing analytical document like worksheet, SOP, STP, product specification and protocol as per pharmacopoeia and as well as regulatory compliance documents.>Formulating OOS/OOT, lab deviation, CAPA and change control as per requirement & activities performed in Trackwise Software.>Ensuring clean & safe working condition for laboratory environment and checking lab compliance such as lab incident.>Responsible for follow-up of analysis status of raw material released and rejection, Scheduled calibration into timely manner.>Formulating budgets, CAPEX (Capital Expenses) and OPEX (Operational Expenses) for Quality resource planning, and empowering juniors for managerial skills.>Ensuring availability of project resources and smooth establishment of products commercially.>Leading internal audits and assessments to identify gaps, facing external audits and closing the gaps on time as per guidelines.>Driving compliance to quality management systems, reporting non-compliances, investigating and identifying the root causes and effectively implementing of CAPA.

Education

• Vinayaka Mission's Research Foundation - University

  MSc. in Chemistry , By Distance Education

  2013 — 2015

• Jamia Hamdard

  Post Graduation Diploma(By Distance Education), Bioinformatics

  2008 — 2009

• University of Rajasthan

  Bachelor of Engineering (B.E.), Biotechnology

  2004 — 2008

Skills

• Fasta
• Chromatography
• Glp
• Ftir
• Pharmaceutical Industry
• Sop
• Fda
• Standard Operating Procedure (Sop)
• Analytical Method Validation
• Calibration
• Technology Transfer
• Sap
• Management
• Regulatory Affairs
• Software Validation
• Cleaning Validation
• Uv/Vis
• Computer System Validation
• Lims
• Corrective and Preventive Action (Capa)
• Qualification of Instrument
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Gmp
• Analytical Chemistry
• Verification and Validation (V&V)
• Laboratory Information Management System (Lims)
• Change Control
• Change Management System Through Trackwise Software System
• Hplc
• Validation
• Capa
• Uv
• Phylip