QC Executive (Bioanalytical)-Vimta Labs, Hyderabad

Experience: 1-3 years in relevant industry

CTC: 3 LPA

Responsibilities:

1. Responsible for monitoring the compliance of all bioanalytical SOPs.
2. Prepare/Review of Validation & Study Protocols, Method STPs & Method Validation Reports, bioanalytical reports and related analytical master files and chromatographic raw data (soft & hard copy).
3. Ensuring the calibration status of all bioanalytical equipment and related instruments and the reference standards status.
4. Review of Qualification and Calibration records of all equipment.
5. Verification of logbooks and temperature recordings of freezers on a regular basis.
6. Ensure the archival of all completed study and validated documents.
7. Review of Audit Trails and back up data.
8. Preparation of responses for QA observations and to take necessary corrective action.
9. Provide Training on bioanalytical SOPs and guidelines to bioanalytical team as necessary.
10. Responsible for Initiation/Review of all QMS documentation such as change controls, deviations and CAPA.
11. Responsible to face Regulatory Inspection and Sponsor audits.
12. Responsible for Initiation/Review of all QMS documentation such as change controls & deviations, CAPA.