Magazine : Vishal Nakrani
Current
Research Scientist-QA at Alem...
Education
Pharmacy M.Pharm(QA)
Vishal Nakrani ’s experience
Research Scientist-Quality Assurance
at
Alembic Research Centre
, Vadodara
Working/Currently
• Preparing audit plan for internal audit in consultation with
Head-Quality Assurance. • External Audit (Performed BA Phase
Monitoring at Lambda Therapeutic Research, Supratech
Lab.) • Protocol Review of BA/BE study. • Performing
System/Process Audit • In process and Retrospective Audit (Raw
data, Chromatogram and Report) of Bio analytical Phase (MV, Study
based) as per GLP, SOPs and Regulatory Requirements. • Audit
of different clinical activities like Screening, Dispensing,
Check-in, Check out, ICF presentation, meal distribution, vitals,
sample separation, samples segregation etc. • Retrospective
audit of Clinical (ICF, Regulatory, CRF, Regulatory binders etc.)
• Audit of Study Reports as per Regulatory Requirement and
SOPs. • Preparation and review of SOPs, Validation
Protocol. • Maintaining the Change Control, Deviation Control
System and related files, register. • Review of calibration,
validation documents. • Training of SOPs, guidelines etc.
Head-Quality Assurance. • External Audit (Performed BA Phase
Monitoring at Lambda Therapeutic Research, Supratech
Lab.) • Protocol Review of BA/BE study. • Performing
System/Process Audit • In process and Retrospective Audit (Raw
data, Chromatogram and Report) of Bio analytical Phase (MV, Study
based) as per GLP, SOPs and Regulatory Requirements. • Audit
of different clinical activities like Screening, Dispensing,
Check-in, Check out, ICF presentation, meal distribution, vitals,
sample separation, samples segregation etc. • Retrospective
audit of Clinical (ICF, Regulatory, CRF, Regulatory binders etc.)
• Audit of Study Reports as per Regulatory Requirement and
SOPs. • Preparation and review of SOPs, Validation
Protocol. • Maintaining the Change Control, Deviation Control
System and related files, register. • Review of calibration,
validation documents. • Training of SOPs, guidelines etc.
Vishal Nakrani ’s education
Pharmacy [M.Pharm(QA)],
ISTAR [2007/June]
, Vallabh Vidhyanagar
Vishal Nakrani ’s additional information
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