Pulugujju Suresh

Worked as Lead monitor for CLinical and Bioanalytical studies.

Clinical data review and clinical trial conduct as per regulatory guidelines

GLP team member ,Quality Assurance lead and researcher in bioanalytical department in CSIR-IICT at Hyderabad

Worked as Instrument Operator in Bioanalytical Department

Sample preparation for routine bio analysis.

Calibration of instruments like pipettes, analytical balance, centrifuge, pH meter and LCMS/MS.

Involved in method developments and Method validations.

Worked as Instrument Operator LC-MS/MS (SCIX).

Performed validations and studies in regulatories like USFDA, EU, WHO and ANVISA etc.

Preparation, review and revision of SOPs, Protocols, Self-Inspections, identification of training needs, conducting GLP trainings, updating quality systems as per the current regulatory requirements as per USFDA, EU, WHO, ANVISA and DCGI

Preparation and Review of New Instruments SOP’s and Global SOP's & other Documents.

Review & Audit of Analytical Documents (Study Data, Development Reports, Validation Protocols/Reports, Method Transfer Protocols/Reports, LNBs)

Working according to safety procedure in Bio-analytical laboratory

Involved in audits like USFDA, WHO, ANVISA and DCGI audits.

Responsible for the GLP compliance Bio-analytical laboratory procedures.

• Used variety of learning modalities and support materials to facilitate learning process and accentuate presentations.