Prabhat Rastogi Email & Phone Number

Dehradun, Uttarakhand, India

• Handling of Drug Product Elemental Impurity Risk Assessment as per ICH Q3D.Handling of Quality Risk Management as per ICH Q9.• Planning and Execution of Validation activities (HVAC/Compressed Air/Water system/ Equipments Qualification/ Computer System validations etc.).• Preparation of compliance report against audit reports• Preparation and Review of SOPs, ANDA Batch records, APQR etc.• Preparation and review of Equipment Qualifications (DQ, IQ, OQ & PQ)• Self-inspection audits (announced and unannounced) as per CGMP requirement• Raw Materials and Packing Materials Vendor Site Audit for Vendor Approval and preparation of Vendor Evaluation Report

Dehradun, Uttarakhand, India

Educationally Master of Science in Applied Microbiology.Extensive experience in pharmaceutical quality assurance in managing, mentoring, and leading a diverse team.Successfully led numerous product technology transfers, dossier filings in different countries, query resolutions, approvals, and commercialization.Handled different regulatory and domestic audits followed by CAPA responses and approvals.Implementation of different softwares in alignment with GAMP and regulatory expectations, also minimized documentation errors, overcoming data integrity breaches, significantly improved the efficiency and compliance of all the departments/systems, thus enabling faster product market release and increased regulatory/GMP compliances.As continuous improvement simplified the process by revising Standard Operating Procedures (SOPs), which has, in turn, enhanced productivity and saved resources effectively.

Derabassi

• To assign jobs to downward team members and follow up of the same• Planning and Execution of Validation and IPQA activities• Preparation of compliance report against audit reports• Preparation and Review of SOPs, Batch records, APQR, Calibration and Preventive maintenance schedules and records etc.• Review of change control, CAPA and deviations• Preparation and review of Equipment Qualifications (DQ, IQ, OQ & PQ)• Preparation of protocols and reports pertaining to process validation• Self-inspection audit as per cGMP requirement• Preparation of Validation Master Plan

Baddi

Worked as Executive-QA:• Planning and Execution of Validation activities• Preparation and review of Validation protocols and reports of Vial Washing Machine (Ambika), Sterilizing Tunnel (Macofar), Bung Processor cum Steam Sterilizer (Machine Fabric) etc.• Process Simulation by Media Fill Studies• Preparation and review of Equipment Qualifications (DQ, IQ, OQ & PQ)• Water system, HVAC System, Compressed Air and Nitrogen validations• Preparation of protocols and reports pertaining to process validationEXPOSURE IN DOCUMENTATION:• Preparation of compliance report against audit reports• Preparation and Review of SOPs, Batch records, APQR etc.• Batch records review and release• Handling of change control and deviations• Part of ANDA team (TBMP, TBM Report, Hold time protocol and Report, BMR & BPR preparation)• Handling, Distribution and Retrieval of Batch records, SOPs, Specifications, STPs etc.• Handling of control samplesEXPOSURE IN IPQA:• Line clearance at all critical stages of manufacturing & packing (Oral and Dry Powder Injection)• Ensuring CGMP and required SOPs followed during manufacturing of drug products• In-process sampling and Analysis of drug product• On-line monitoring, Verification & Review of documents• Collection of samples: Semi-Finished, Finished and Control Samples• To ensure GDP across manufacturing operations• Review of Batch records• Monitoring dispatch related activities and documentation for the same• Coordinating all IPQA activities

Nalagarh, Himachal Pradesh, India

• Line clearance at all critical stages of manufacturing• Ensuring CGMP and required SOPs followed during manufacturing of drug products• In-process sampling and Analysis of Oral drug product• On-line monitoring, Verification & Review of documents• Collection of samples: Rinse/Swab, Semi-Finished, Finished and Control Samples• Review of Batch records• Monitoring dispatch related activities and documentation for the same• Calibration of IPQA instruments• Part of Validation team (Execution of manufacturing and packing processes)• Shop floor observations report generation and submission to QA

Haridwar, Uttarakhand, India

• Line clearance at all critical stages of manufacturing• Ensuring CGMP and required SOPs followed during manufacturing of drug products• In-process sampling and Analysis of Oral drug product• On-line monitoring, Verification & Review of documents• Collection of samples: Rinse/Swab, Semi-Finished, Finished and Control Samples• To ensure GDP across manufacturing operations• Review of Batch records and release of Finished Goods• Calibration of IPQA instruments• Handling of control samples• Mobile phase preparation for analysis of different products by HPLC• Packing material analysis and report generation• Wash water sample analysis and report generation• Water testing by KF Titrator• pH testing of water by pH Meter

Master Of Science - Ms, Applied Microbiology, First

Applied Microbiology

Bachelor Of Science - Bs, Natural Sciences, First

Chemistry, Zoology, Botany