Dipeeka Prajapati
Ahmedabad
Summary
Dynamic quality assurance professional with extensive experience at Cliantha Research, excelling in audit coordination and SOP development. Proven leadership in ensuring compliance and enhancing data integrity, while effectively managing calibration processes. Recognized for strong teamwork and a commitment to maintaining high regulatory standards in all projects.
Overview
8
8
years of professional experience
Work History
Sr. QA auditor - I
Cliantha research
05.2025 - Current
- Ensured compliance with SOPs, protocols, and regulatory standards by reviewing retrospective sample analysis, method validation, and audit reports.
QA auditor
Cliantha research
09.2023 - 04.2025
- Ensured compliance with SOPs, protocols, and regulatory standards by reviewing retrospective sample analysis, method validation, and audit reports.
- Led in-process study and system audits, coordinated sponsor/regulatory inspections, and resolved compliance findings.
- Managed laboratory equipment calibration data, maintained master instrument lists and schedules, and coordinated temperature monitoring with QMS.
Sr. Officer as Quality monitor
Cliantha research
11.2022 - 09.2023
- To ensure that all study data is reviewed in accordance with SOP, protocol, and regulatory standards.
- Compile projects for archiving reconciliation of forms after completion of study, review draft and final protocol in accordance with respective guideline.
QC Monitor
Veeda Clinical Research organization
01.2021 - 10.2022
- Ensured 100% evaluation of research data in strict compliance with SOPs, study protocols, and regulatory standards.
- Managed archiving and retrieval of hard-copy study documents, ensuring traceability and easy access.
- Conducted comprehensive reviews of method development processes, including SOPs, study plans, method validation data, reports, and amendments.
- Oversaw calibration data for laboratory equipment, maintaining and updating calibration schedules and records.
- Monitored data logger readings and temperature recorder graphs to ensure process integrity and compliance.
QC officer
Synchron Research Service Pvt Ltd
09.2020 - 12.2020
- To ensure 100% research data evaluation in accordance with SOP/Protocol/regulatory standards.
- Archiving and retrieving hard copies for study data, 30% in-process audits in study and method validation data.
QC Associate
Lambda Therapeutic Research Ltd
06.2018 - 08.2020
- Retrospective review of 100 % Method validation, calibration and study raw data generated to ensure that all the documents are accurate.
- Preparation of Method Validation Reports.
- To report any abnormal results, identified during QC and QA audits.
- Maintenance of master list of instrument and generate instrument ID to new instrument.
- Tracking, review and maintenance of calibration schedule /calibration records.
- Review data logger readings, graphs of temperature recorder provided by the process person.
- Co ordinate with QMS regarding generation of control documents.
- Checking of freezer temperature data.
- Assist QA auditor during facility inspection.
Education
B.Pharm -
L.M College of Pharmacy
Ahmedabad05.2018
HSC -
R.D. Vidhya Vihar
Ahmedabad05.2014
SSC -
Bhavana Vidhyalay
Ahmedabad05.2012
Skills
- Leadership
- Teamwork
- Punctuality
- Flexibility
- Time Management
- Creative Learning Strategies
- Computer Proficiency
- SOP development
- Quality assurance
- Audit reporting
- Audit coordination
Awards
- Participated ENIGMA 16” in Nirama institute of Pharmacy competition on “Pharma AD”, 02/01/16
- Participated in Volleyball tournament & Jashn-E-Azadi competitions, L.M. Pharmacy College
Job Title
QA Auditor
Activities
- Data Integrity, 08/22/18, Lambda Therapeutic Research Ltd, Ahmedabad
- Advance auditing Skills – Data Integrity, 11/19/18, Lambda Therapeutic Research Ltd, Ahmedabad
- GOOD LABORATORY PRACTICE, 03/02/19, Lambda Therapeutic Research Ltd
- Basics of 21 CFR 11, EU Annex 11 and OECD Guidelines for Computerised systems, 05/01/19, Lambda Therapeutic Research Ltd, Ahmedabad
Timeline
Sr. QA auditor - I
Cliantha research
05.2025 - Current
QA auditor
Cliantha research
09.2023 - 04.2025
Sr. Officer as Quality monitor
Cliantha research
11.2022 - 09.2023
QC Monitor
Veeda Clinical Research organization
01.2021 - 10.2022
QC officer
Synchron Research Service Pvt Ltd
09.2020 - 12.2020
QC Associate
Lambda Therapeutic Research Ltd
06.2018 - 08.2020
B.Pharm -
L.M College of Pharmacy
HSC -
R.D. Vidhya Vihar
SSC -
Bhavana Vidhyalay