Dr. Prashant Tripathi Email & Phone Number

Ahmedabad, Gj, In

Ahmedabad, Gujarat, India

1. Oversee the quality assurance team and ensure compliance with all regulatory requirements and internal standards.2. Implement and maintain quality management systems to ensure product quality and safety.3. Develop and execute strategies for process improvement and optimization.4. Conduct regular audits and inspections to ensure adherence to quality standards.5. Collaborate with cross-functional teams to address quality-related issues and implement corrective actions.6. Train and mentor staff on quality assurance processes and regulatory compliance.7. Monitor and report on quality performance metrics to senior management.8. Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance and best practices.

Ahmedabad, Gujarat, India

Ahmedabad

• R&D QA Incharge ( CQA SME) and leading a team of QA inspectors working for Analytical (GMP), Small molecule bioanalysis (BA/BE, phase 1-3 clinical trial), Large molecule bioanalysis (LBA, Immunogenicity, biosimilar) & IT compliances to ensure internal audits are effectively performed, findings reported to management and CAPA implementation• More than 8 Indian and international CROs (Canada & Italy) audited for BA/ BE, Clinical trial, Bioanalytical, Biosimilar Immunogenicity, IVRT studies• Implemented efficient and compliant auditing program as per company SOPs (Standard Operating Procedures), GxP (e.g. GCP, GLP, GMP, GDP, etc.) and clinical trials regulations. • Provided expertise on the design, implementation and development of GxP, systems, processes and procedures. • Review of study protocol, auditing of method validation, study raw data and study report• Reviewing and guiding internal auditors on chromatography data (HPLC, LC-MS/MS) and ELISA• Conduct the risk assessment, risk mitigation , trend analysis, CAPA, deviational and incident management• Review and response drafting of regulatory deficiency letters and hosting of regulatory audits (USFDA/ANVISA/NGCMA etc)

India

1. Managed a team of Bioanalytical QA auditors working for large molecule bioanalytical assays (ELISA, MSD, Biacore, Watson LIMS)2. Responsible for work distribution, training, meeting project time-lines, coordinating with other departments.3. Supervised and verified the calibration and validation Data (DQ/IQ/OQ/PQ) of instrument and equipments4. Preparation and reviewing of QA and management SOPs as per GLP/GCLP.5. Plan and Conduct audit of study protocol and retrospective audit of bio-analytical raw data as well as Bio-analytical report and Method Validation (raw data and report / addendum) as per the regulatory guidelines, in-house SOP’s and protocol.7. Plan and perform study-based inspections at various phases of the study; facility-based and process-based inspections to assure the compliance with the principles of GLP/GCLP (Preclinical/clinical studies) and retention of all inspection records.8. Promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable;9. Inspection of computer system validation and qualification as per 21 CFR part 11 compliance.10. Prepare and sign a QA statement to be included in the report.11. Support for the external vendor qualification audit program

Chennai Area, India

 Handling team of bioanalytical auditors and responsible for work distribution, training, meeting project timelines, coordinating with other departments. Plan and Conduct audit of study protocol and retrospective audit of bio-analytical raw data as well as Bioanalytical report and Method Validation (raw data and report / addendums) as per the regulatory guidelines, in-house SOP’s and protocol. Internal Quality Monitor and Controller. Effectively involve in all high profile Regulatory /sponsor’s specific audit. Responsible for the over all documentation of the Analytical Area. Supervised and ensured the calibration and validation Data (DQ/IQ/OQ/PQ) of instrument and equipments Responsible for preparing, reviewing and the issuance of the raw data sheets for analysis Review of test reports and related documents. Maintaining the records as per the regulatory requirement. Developing and implementing GLP strategy to support the existing one and modifying it wherever required. Preparation, implementation and monitoring of the Standard Operating Procedures in co-ordination with the BA Department. Laboratory supervision and updating. A facilitator to impart Quality education.  Successfully Faced USFDA,ANVISA,DCGI Inspection

Ahmedabad Area, India

Lambda is milestone in my career as I could implement my good learning over their (Advance Bioanlytical Lab)and further, I learnt basics of Bioanalysis, HPLC, LC-MS/MS, GCP, GLP and Management, and acquired desired scientific and mangerial skills and confidence to create and run a scientifically sound Bioanalytical Lab efficiently.1. Responsible for Method development, validation and sample analysis in biological matrix mainly using HPLC (SHIMADZU-LC Solution) and LC-MS/MS (MDS SCIX,WATERS QUATTRO PREMIER XE),2. Responsible for Developing sample processing methods such as Protein Precipitation, Liquid –Liquid extraction and Solid phase extraction.To work on different USFDA and EU projects as using HPLC and LC-MS/MS by using SDMS (Scientific Data Management System) Nugenesis software.3. Data generation and SOP’S preparation for Projects, Method validation and Method development. 4. Documentation of all the activities carried out in Bio-analytical Department.5. To ensure overall compliance with the guidelines (e.g. USFDA, ANVISA, etc.)6. To work maintaining GLP norms.7. Other responsibilities include keeping our self-updated with the recent trends & methodologies, suggestions to improve the documentation as practices during work.

Ph.D, Bioanalytical Chemistry

HPLC Method development and its characterisation for quantitative analysis of drug in human matrix

M.Sc.Ica, Analytical And Instrumental Chemistry

Activities and Societies: During my M.Sc. I learned about analytical techniques and instrument widely using in Pharmaceutical research.

Education record