Assoc II, Lab QA

Job Description:

Responsibilities

• To review of analytical documents generated during the analysis of QC, Stability and Microbiology for adequacy and accuracy.
• To carry out investigation in-case of out of specification (OOS) and deviation and take the corrective and preventive action (CAPA).
• To ensure the calibration of all the analysis instruments is accurate.
• To sign off electronically the final document of sample set generated through Empower and all other software where (E-signature is applicable) for all the analysis in QC, stability & microbiology.
• To ensure the preparation of working standards as per the guidelines and pharmacopoeias.
• To review of calculation of the respective test protocol and daily release status.
• To ensure online recording and documentation of all the data related to the testing on daily basis and ensure the tractability of the same.
• To check the record of preparation of the reagent and volumetric solutions.
• To prepare SOP as per the change proposal.