Keerthana Krishna

• Handling of QMS-related activity. Responsible for ensuring the overall compliance of GxP computerized systems at the site.
• Managed change control, deviations, and observations in accordance with GxP.
• Requirements and regulatory standards. Implemented corresponding corrective measures and addressed preventive actions and corrective actions (CAPA) using TrackWise.
• Review SOPs, IOPs, method validation protocol, and Method verification Report. Review all documentation activity as per SOPs.
• Conducted thorough investigations into data integrity in line with SOP guidelines.
• Supported documentation work for Internal Audits, Customer Audits, and Regulatory requirements.

Regular task:

• Team management and assigning the work to team members.
• Molecular techniques like extraction of nucleic acid (DNA/RNA), RT-PCR, and NGS library preparation of Oncology and Hemato-oncology.
• Carrying end-to-end process.
• Communication to clinician, vendors, and required team members for effective workflow.
• Responsible for each and every individual sample report, maintaining the quality.
• Handling Deviation, CAPA and other Quality related Documentations

Achievements:

• Published review paper titled " A molecular approach to the diagnosis, Prognosis and treatment of BCR-ABL1-Positive chronic Myeloid Leukemia" in the journal of cancer and oncology- Medwin publisher - USA

• Senior Research Associate and Team lead: April 2022
• Research Associate: April 2021 - April 2022
• Research Associate Trainee: Sep 2020 - April 2021

Regular tasks:

• Extraction of Nucleic acid from FFPE Blocks and Blood.
• Performing Droplet Digital PCR and Real-time PCR assays for Oncology and Hemato-oncology clinical samples - EGFR, BRAF, KRAS, NRAS, BCR-ABL, PML-RARA AML, MGMT. etc
• Data Analysis and Reporting.
• Validation and developing the assays for AMOYDX, TRUPCR, and other diagnostic kits.
• Library Preparation for NGS.

Achievements:

Received the Star employee of the year 2021 award at MedGenome Labs Ltd.