Balraj Rana

Senior Executive @Macleods Pharmaceuticals Ltd

IN

Working in QC department as a Reviewer• Developing and maintaining a product development pipeline aligned with the company\'s strategic objectives through quality initiatives.•Setting up, positioning, and maintaining the quality management system (QMS). Addressing the needs of a quality management system at the labs - to improve or support quality or requirements. • Ensuring promptness in mitigating & identifying the risks impacting quality within the food production. Playing a stellar role in creating and implementing all the prevention strategies to avoid potential issues.• Performing quality control analysis, including tests and inspections of processes.•Developing and executing quality procedures to ensure quality is maintained.•Shoulder with the entire responsibility of spearheading the daily activities in GLP Section• Leverage deviation, OOS, OOT, Incidence, self-inspection, or other regulatory observation to identify and investigate the triggered non-conformance• Working on the Track Wise system to manage all the QMS activities.•Managing a whole gamut of functions, such as submitting the investigation report, executing CAPA and other deviations, and altering the controls in QC.• Assessing and evaluating all the Calibration data of all instruments in QC Lab.• Conducting the system audit trial of all QC instrument Software, including standalone and Chromeleon software. Coordinating the out-of-calibration and laboratory incident activity.•Prioritizing and carrying out the random review of ongoing analysis.•Evaluating a new instrument\'s protocol and report (IQ, OQ, PQ).• Scheduling and imparting training related to the Data integrity module and 21 CFR part 11.• Executing the GXP assessment and gap analysis of QC instruments.• Driving the software up gradation of the instrument.• Providing leadership and strategic direction to all the staff in maintaining quality and inspecting the Pharmaceutical and Health Biotech labs.

Himachal Pradesh University , Shimla

Bachelor of Science - BS, Chemistry