Divya Kandan
Chennai
Summary
I'm a Post-graduate in Applied Microbiology with 2.8 years experience as TMF Specialist-1 and 1.7 years experience in Quality Assurance. I'm looking for an opportunity in your organization for growth in my professional career, and I also want to contribute to the growth of the organization.
Overview
5
5
years of professional experience
1
1
Certification
Work History
TMF Specialist -I
ICON Clinical Research Pvt Ltd
Chennai
01.2023 - Current
- Utilized eTMF (Electronic Trial Master File) systems like Veeva vault and wingspan (ICOMaster) to manage and organize clinical trial documents.
- Ensured the accuracy and completeness of all clinical trail documents.
- Involved in Scanning, Indexing of documents and Audit ready checks on individual documents uploaded in the eTMF system for every study.
- Supported conversion projects that involved efficiently migrating documents between eTMF platforms on schedule, accompanied by the preparation of SOPs and comprehensive data reconciliation to ensure accuracy and consistency.
- Exports and reconciles study metrics reports, and if required analyzes and identifies issues.
- Performed File Review activities, Structural & Coherence Quality review activities. Actively involved in Internal Audits & Client Audits.
- Prepared the eTMF for Quality Assurance (QA) or sponsor audits, and resolved any findings by identifying and implementing corrective actions. Supported Robotic Process Automation (RPA) and integration process.
- Supported Data Management activities including discrepancy review, query generation and resolution.
- Managed clinical data processes, including data collection, integration, validation, discrepancy resolution, and availability checks.
- Designed and maintained clinical trial reports using PL/SQL, J-review and database programming techniques.
- Actively engaged in mentorship by guiding new joiners through the process, performing quality checks and conducting training sessions. Involved in team activities like knowledge sharing sessions by collecting and presenting the process related topics.
Quality Assurance Officer
SMS Labs Services Private Limited
Tiruvallur
12.2020 - 07.2022
- Preparation and maintenance of Quality System Documents according to various accreditations and licensing standard requirement like ISO 17025:2017, Drugs & Cosmetics etc.
- Investigation of non-compliance includes root cause analysis, Corrective Actions, Preventive Action and implementation.
- Carry out quality tests by scheduling and participating in ILC/PT programs, Internal Quality Checks.
- Prepare plans and conduct both internal and external training of employees.
- Statistical analysis of analytical results and other aspects of ensuring validity of results.
Education
M.Sc - Applied Microbiology
Ethiraj College For Women
Chennai01.2020
B.Sc - Microbiology
Bhaktavatsalam Memorial College For Women
Chennai01.2018
HSC -
Christ King Matric, Hr, Sec School
Tiruvallur01.2015
SSLC -
Christ King Matric, Hr, Sec School
Tiruvallur01.2013
Skills
- ICH and GCP guidelines
- Project management
- Microsoft Office suite
- Timeliness and flexibility
- Written and verbal communication
- ICOMaster & Veeva Vault expertise
- Data reconciliation
- PL/SQL programming
- J-Review
Certification
- A 3 months of online course completion certificate on the basic concepts and work flow in Clinical Research, Clinical Data Management, Pharmacovigilance, Medical writing and Regulatory Affairs from CliniWings (ISO & MSME certified) Pharma Experts Institute, 10/2022, 12/2022
- Good Clinical Practice from NIDA Clinical Trials Network, 09/2022
- Certificate course in Pharmacovigilance from Udemy, 08/2022
Publications
Amylase Production by Aspergillus niger and Penicillium Species by Solid-State and Submerged Cultivation Using Two Food Industrial Wastes, Journal Nature Environment and Pollution Technology, 20, 3, 1127-1135, 2021, https://doi.org/10.46488/NEPT.2021.v20i03.020
Awards
Inspire Award - Efficiency and Team work, 08/2024, Recognized for successful completion of migration project.
Languages
- English - Full Professional Proficiency
- Tamil - Native
Timeline
TMF Specialist -I
ICON Clinical Research Pvt Ltd
01.2023 - Current
Quality Assurance Officer
SMS Labs Services Private Limited
12.2020 - 07.2022
M.Sc - Applied Microbiology
Ethiraj College For Women
B.Sc - Microbiology
Bhaktavatsalam Memorial College For Women
HSC -
Christ King Matric, Hr, Sec School
SSLC -
Christ King Matric, Hr, Sec School
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