Group Leader QC - Bioanalytical - Vimta Labs
Group Leader QC - Bioanalytical - Vimta Labs
Posted on :
08-04-2025
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1 Vacancy
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Job Description
Group Leader QC Bioanalytical Vimta Labs Cherlapally
GLQC
Primary Responsibilities:
- Responsible for Initiation/Review of all QMS documentation such as change controls & deviations CAPA.
- Responsible for monitoring the compliance of all bioanalytical SOPs.
- Prepare/Review of Validation & Study Protocols Method STPs & Method Validation Reports Bioanalytical reports and related analytical master files and chromatographic raw data (soft & hardcopy).
- Review of Audit Trails and back up data.
- Preparation and Reviewing of SOPs.
- Responsible for sponsor and regulatory audits.
- Preparation of responses to Regulatory and Sponsor queries.
- Preparation of responses for QA observations and to take necessary corrective action.
- Provide Training on Bioanalytical SOPs and guidelines to bioanalytical team as necessary.
Secondary Responsibilities:
- Ensuring the calibration status of all bioanalytical equipment and related instruments and the
Reference standards status.
- Review of Qualification and Calibration records of all equipment
- Verification of log books and temperature recordings of freezers on regular basis.
- Ensure the archival of all completed study and validated documents.
- Ensure mapping and calibration of the cold storage room.
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Employment Type
Full-Time
Key Skills
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