Perform analysis and tests of drug products, raw materials, in-process materials, release test samples, stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance with established specifications.
Preparation of reagents/diluents/ dissolution media as per STP.
Perform a various qualitative tests or qualitative assays on samples using modern and automated instrumentation.
Utilize electronic laboratory information systems such as LIMS for acquisition and processing of analytical data.
Ensure implementation of SOP for all corresponding activities.
Write controlled documentation related to QC Laboratory operations or testing such as SOP's, analytical protocols, analysis reports and forms.
Ensure real time documentation, maintain data integrity and appropriate traceability.
Assist in maintenance and calibration of test instruments per specifications.
Responsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentation.
Responsible for checking all results in LIMS/RDS and reporting of any observed results that do not meet the requirement (OOS/OOT/Deviation) for further investigation.
Destruction of expired finished products/ raw material samples as per SOP and recording the same in the register.
Responsible for QC lab and equipment/instrument cleanliness.
Responsible for procuring and receipt of QC lab glassware and consumables.
Any other activities as and when assigned by the Superior.
