Data Reviewer Calibration Support Executive

Job Description

Role Overview Responsible for review of qualification & calibration data of instruments and equipment as per procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Analytical instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to anticipate the implications and consequences of situations and take appropriate actions in the interest of Client as well as Cal Scientific without compromising quality. Clear thoughts and effective and crisp communication. Job requirement M.Sc – specializing in Chemistry/ M. Pharma with proven experience of min. 7-8 yrs. in Instrument qualification and calibration. In depth experience in Chromatography (HPLC, UPLC, GC), Spectroscopy (MS, FTIR, UV), Thermal techniques (DSC, TGA) and Particle size measurements. Expertise in analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities.