Bioanalytical-QC

Role & responsibilities

• To ensure quality control activities through monitoring operational activities of the laboratory in compliance with in-house SOPs and regulatory requirements.
• GLP compliance support (perform/review calibrations, labelling requirements, working standard management, review of chemical inventory and utilization of consumables).
• All study related QC activities are performed as per in-house SOPs, STPs, Protocol and Plans.
• Online/In-process review of prerequisites of MV (Literature, Cmax, Pharmacokinetic and metabolite details), compliance review of MV, bioanalytical processes associated data and ALCOAC.
• Verification of matrix, study sample receipt, handling, storage and usage.
• Project tracking and monitoring track sheet.
• Review of BA reports against raw data.
• Data compilation and review.
• QC checklist maintenance and signoff.
• Review of training records of new joiners and relieving employees.
• For Bioanalytical ANDA and eCTD internal coordination and review.

Preferred candidate profile

The candidate should have minimum 3+yrs experience in Bioanalytical department and interested to work in QC role.