Dixitkumar Patel Email & Phone Number

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat, India

• Conduct an audit in Bioanalytical department including system audit, In-process audit, retrospective audit, vendor audit etc. as per requirement of Quality assurance department.• Review of Bioanalytical report, study plan, protocols, standard operating procedure (System SOPs and LCMSMS related method SOPs of Bio analytical department), CAPA, change control, Deviation, Risk assessment, Incidence report, Investigation report and other documents related vendor qualification. • Handling of Electronic software like Biolyte (Management of Concentrations of study samples) , Document management system (DMS), Training management system (TMS), Deviation, CAPA, Change control and Incident report Management, Archive management of hardcopy as well as electronic data of projects and non project specific data.• Ensure the compliance of GLP for Bio analytical laboratory.• Plan and carry out In-process audits of study activities in Clinical Pharmacology & Medical Affairs department like dispensing activity, dosing, meal distribution, phlebotomy, Alco/Urine scan, informed consent presentation, compliance check, check-in activity and sample separation etc• Conduct retrospective audits of study related raw data like, Informed Consent Forms records, Medical screening record, Investigational Medicinal Product forms, Clinical raw data like Case Record Forms, General Case Record Forms and sample separation records.• Review of Clinical Study Protocol, incident report, investigation report or other study specific documents.• Conduct system audit as per schedule, preparation of audit report and ensuring compliance in Clinical Pharmacology & Medical Affairs department, clinical pharmacy and other assigned area.• Prepare and review of Quality assurance SOPs and review of Clinical Pharmacology and Medical Affairs, Medical Writing, clinical pharmacy and other cross functional SOPs for correctness, adequacy and completeness.

Ahmedabad, Gujarat, India

• Set up and conduct analytical experiments, tests and analyses using techniques such as chromatography, Mass spectroscopy, physical and chemical separation techniques to analyze chemical or biochemical compounds. • Conduct fundamental and applied research into the analysis of drug available in matrix like plasma, blood, serum or urine to execute analysis of clinical studies of Phase I to IV or any GLP study.• Operate and maintain laboratory equipment and apparatus i.e. pH meter, weigh Balance, Evaporator, Different type of Vortex shaker and Mixer, Incubator, LCMSMS of different specification i.e. Waters QPXE, API 4000™ LC-MS/MS System - Sciex, etc.• Perform Sample extraction activity (LLE, SPE, PPT) for study sample analysis, Method validation and Method development with manual extraction and liquid handling systems (LHS) like TICAN and Hamilton systems.• Prepare solutions of liquid and reagents having different strength to develop Method for analysis on Liquid Chromatography with tandem mass spectrometry. • Compile records after obtaining results from different experiment of Method development and Method validation as per different regulatory guideline. • Data interpretation of different experimental and analytical results must be recorded for any failure of experiment and Investigations during Method development, Method Validation and study sample analysis.• Prepare failure investigation report and Investigation report for any analytical failure during study sample analysis and method development. • Overall responsible for compliance of Bio analytical study (BABE), Method validation and development. • Coordinate with Bio analytical Head, Lab manager or Group leader if any concern regarding sponsor or regulatory.

Dholka

• Set up and conduct analytical experiments, tests and analyses using techniques such as chromatography, Mass spectroscopy, physical and chemical separation techniques to analyze chemical or biochemical compounds. • Conduct fundamental and applied research into the analysis of drug available in matrix like plasma, blood, serum or urine to execute analysis of clinical studies of Phase I to IV or any GLP study.• Overall responsible for Method development, Method Validation and study sample analysis for BA BE study analysis.• Coordinate with Bio analytical Head, Lab manager or Group leader if any concern regarding sponsor or regulatory. • Prepare solutions of liquid and reagents having different strength as per Method SOP for routine study analysis, Method validation and Method development.

Ahmedabad, Gujarat, India

• Conduct fundamental and applied research into the analysis of drug available in matrix like plasma, blood, serum or urine to execute analysis of clinical studies of Phase I to IV.• Compile records after obtaining results from different experiment of Method development and Method validation as per different regulatory guideline.• Prepare Bio analytical report after completion of study sample analysis.• Coordinate with clinical regulatory team for eCTD submission for Bio analytical report.• Communicate with sponsor for any regulatory query and prepare justification to resolve the query after coordinate with Lab Manager and Bio analytical Head.

Vadodara Area, India

• Conduct fundamental and applied research into the analysis of drug available in matrix like plasma, blood, serum or urine to execute analysis of clinical studies of Phase I to IV.• Perform extraction activity for study samples via different extraction method like LLE, SP, PPT in Bio analytical Laboratory.• Perform daily calibration activity for weigh balance, pH meter.• Maintain accountability of working standard and respective documents. • Document experimental results, analyze data and outcomes and communicate results with the team.• Achieve project objectives by troubleshooting experiments and testing practical and creative solutions.• Synthesize and utilize key information from the literature as necessary to achieve objectives during Method development.• Handling of Clinical study samples for Bio analysis.• Performing routine and daily calibration of PH meter and weigh balance.

The Master Of Pharmacy, Pharmaceutical Quality Assurance

Bachelor Of Pharmacy (B.Pharm.), Pharmacy