Group Leader QC - Bioanalytical - Vimta Labs, Cherlapally

Minimum:

1.  Doctorate/master’s degree in pharmacy/Analytical Chemistry/organic chemistry.

2.  Minimum 8-12+ years of experience in QC - Bioanalytical division.

3.  Should have knowledge on Microsoft word and excel and English communication skills.

Desirable:

1.     Responsible for Initiation /Review of all QMS documentation such as change controls & deviations, CAPA.

2.     Responsible to monitor 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 & hard copy)

4.     Review of Audit Trails and back up data.

5.     Preparation and Reviewing of SOPs.

6.     Responsible to face 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. Ensuring the calibration status of all bioanalytical equipments and related instruments and the reference standards status.

10. Review of Qualification and Calibration records of all equipments.

11. Verification of log books and temperature recordings of freezers o regular basis.

12. Ensure the archival of all completed study and validated documents.

13. Ensure mapping and calibration of the cold storage room.

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