Group Leader QC – Bioanalytical – Vimta Labs

Group Leader QC – Bioanalytical – Vimta Labs, Cherlapally

Minimum

• Doctorate/masters degree in pharmacy/Analytical Chemistry/organic chemistry.
• Minimum 8-12+ years of experience in QC – Bioanalytical division.
• Should have knowledge on Microsoft word and excel and English communication skills.

Desirable

• Responsible for Initiation /Review of all QMS documentation such as change controls & deviations, CAPA.
• Responsible to monitor 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 & hard copy)
• Review of Audit Trails and back up data.
• Preparation and Reviewing of SOPs.
• Responsible to face 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. Ensuring the calibration status of all bioanalytical equipments and related instruments and the reference standards status.
• Review of Qualification and Calibration records of all equipments.
• Verification of log books and temperature recordings of freezers o regular basis.
• Ensure the archival of all completed study and validated documents.
• Ensure mapping and calibration of the cold storage room.

Interested candidates can share their profiles to [email protected]