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7.0 - 10.0 years
6 - 12 Lacs
Mumbai, Thane
Work from Office
Role Overview Responsible for qualification & calibration activities for defined instruments and equipment as per schedule & 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. 8-10 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. Job Location-Mulund
Posted 1 week ago
2.0 - 5.0 years
3 - 5 Lacs
Pune
Work from Office
Role & responsibilities Monitoring the temperature & cleaning in QC area. Daily verifications of balance & pH meter. Preparation & Standardization of Volumetric solutions & there consumption records. Water sampling & analysis. Reagents & Buffer preparation & their records. Sampling & analysis of Raw Material, Packaging material, Semi Finished Products, Finished Products & retesting materials. Their documentation. Preparation & analysis of Working standards. Trace Sampling & analysis. ETP water analysis. Preparation of Specifications & raw data. Calibrations of instruments. Process validation & Hold time study of SFP. Updation of Raw Material, Packaging material, Semi Finished Products, Finished Products & retesting materials in SAP. Stability analysis.
Posted 4 weeks ago
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