To follow Good Laboratory Practices, Safety measures and good documentation practices and adherence to data integrity and data governance procedure while working.
To follow Standard Operating Procedures and Standard Test Procedures while working with appropriate PPEs.
To ensure user management and data security policy as laid down by the company
Complete self-training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task.
To perform routine activities as per safety norms.
Supervise compliance to all cGMP, cGxP, or any other regulatory requirements, including EH&S requirements.
Complete self-training and monitor training of team members on the relevant SOPs.
Report any quality concerns or suggestions for improvements to section heads, QC head and quality head.
Execute and supervise all tasks and activities as per the applicable SOPs.
Review and data processing of all QC analytical reports of all sections such as stability, finished products, raw materials, packaging materials, validation, and in-process as per specifications/STP, CTP, GTP etc. and with contemporaneous documentation.
To ensure timely review of QC reports, standalone/server-based computer systems data and its audit trails. To ensure the integrity of data generated on these systems.
To ensure proper investigation of OOS/OOT/OOC of samples/instruments/equipment results as per standard documents.
To ensure cross verification of instrument calibration status label in laboratory.
To conduct lab rounds to maintain good laboratory practices.
To run query in Chromeleon software and ensure status of acquired samples.
To review of single sequence prior to analysis.
To ensure locking of sequences after review of data.
To ensure lock of data pertaining to finished products, intermediate, raw material, working standards and calibration in SAP.
To ensure the use of correct and current version of specification/TDS/protocol/CDS during analysis.
To ensure validity of calibrators used during calibrations.
To ensure preparation record of mobile phase, resolution solutions, volumetric solutions, reagent solutions, primary standards and analytical standards and usage within assigned validity periods.
To ensure proper keeping of reference standards, working standards and test standards and calibration in SAP
Regular participation in internal and external training programs.
The above list is not exhaustive and may be assigned additional responsibilities from time to time.
To ensure proper functioning and approval of IT-QA related activities
