QC

B.Pharm / M.Pharm / M.Sc . Expertise in analysis on HPLC, GC, Assay, Dissolution. Method Validation Protocol creation and execution, Expertise in handling HPLC, ICPMS, GC etc. USV Private Limited

Bachelors Degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences or equivalent experience.

Responsible for execution and review support of Quality Assurance activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements.

Strong knowledge of Quality Agreement / Technical Agreement drafting and review. Practical experience in vendor risk assessment, approved vendor list management and periodic vendor requalification.

Knowledge of Injectable plant in Validation of injection filing line, Lyo, Autoclave, DHS etc & Knowledge of QMS 

Review and approval of analytical documents, raw data, audit trails, calibration/PM records, analyst qualification documents, and reference/working standard qualification records in compliance with GMP and data integrity requirements.

Supervises vial manufacturing activities, including dispensing, washing, sterilization, and filling. Manages online documentation for logbooks, BMRs, and BPRs. Executes change controls via TrackWise and updates SOPs, URS, and Quality Risk Assessments to ensure regulatory compliance.

HPLC, GC, RM, PM, IP/FP, LIMS, Stability, Sampling, Wet Analysis, MT, MV.