Experience Required : B.Pharm / M. Sc. with 2-4 years of experience in Chemical & Instrumental analysis QC (Finished goods & stability). Approved chemist licensed candidate shall be preferred. Well versed with CAPA, GMP Documentation, should have exposure to regulatory audits such as MHRA, USFDA etc.
Followings will be the responsibilities of the position holder :
- Analysis of Stability Samples/ Finished Products as per respective STP/Specification in Quality Control of Hormone block.
- Calibration of routine usage instruments such as Balance, pH meter and Conductivity meter, as and when required.
- Timely analysis of stability sample (Hormone block) and report if any abnormality observed.
- Timely Charging & withdrawal of samples from Stability Chambers & their documentation within the time frame.
- Sample reconciliation and destruction record of stability sample.
- Implementation of GLP / GMP requirements.
- Coordinating and aligning the practices and procedures in line with the COBC requirements
- Stability sample charging, Withdrawal, Reconciliation and data entry in software such as LIMS.
- Completion of assigned trainings of GLP/GMP on time
- Reporting of stability/Finished product sample as per report received from outside Laboratory and check the compliance against respective specifications.
- Evaluates the analysis results as per SOP and report to the supervisor for any abnormality.
