Senior Officer QC -

Role Description

• Initiate, execute, and monitor stability studies for injectable products (real-time, accelerated, and ongoing).
• Sampling, testing, and documentation as per approved stability protocols.
• Perform chemical, physical, and microbiological testing of stability samples as applicable.
• Maintain stability chambers (temperature & RH monitoring) and ensure compliance.
• Review and trend stability data; identify OOS/OOT results.
• Prepare and review stability reports for regulatory submissions and annual product reviews (APQR/PQR).
• Support regulatory inspections and audits related to stability data.

Water Analysis (PW, WFI, RO)

• Perform routine chemical and microbiological analysis of water samples as per pharmacopeial requirements (IP, USP, EP).
• Conduct TOC, conductivity, pH, endotoxin, and mic...