Group Leader QC - Bioanalytical - Vimta Labs, Cherlapally

GL-QC

Primary Responsibilities:

1. Responsible for Initiation/Review of all QMS documentation such as change controls & deviations, CAPA.
2. Responsible for monitoring the compliance of all bioanalytical SOPs.
3. Prepare/Review of Validation & Study Protocols, Method STPs & Method Validation Reports, Bioanalytical reports and related analytical master files and chromatographic raw data (soft & hardcopy).
4. Review of Audit Trails and back up data.
5. Preparation and Reviewing of SOPs.
6. Responsible for sponsor and regulatory audits.
7. Preparation of responses to Regulatory and Sponsor queries.
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.

Secondary Responsibilities:

1. Ensuring the calibration status of all bioanalytical equipment and related instruments and the

              Reference standards status.

1. Review of Qualification and Calibration records of all equipment
2. Verification of log books and temperature recordings of freezers on regular basis.
3. Ensure the archival of all completed study and validated documents.
4. Ensure mapping and calibration of the cold storage room.                         

Interested candidates can share their profiles to keerthana.rojanala@vimta.com