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

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.

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)

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

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

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

Master Of Science - Ms, Applied Microbiology, First

Applied Microbiology

Bachelor Of Science - Bs, Natural Sciences, First

Chemistry, Zoology, Botany