KISHOR KALEKAR
Senior Officer - Lab QA at Rubicon Research Pvt Ltd- Claim this Profile
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Bio
Experience
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Rubicon Research Pvt Ltd
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India
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Senior Officer - Lab QA
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May 2023 - Present
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Encube Ethicals
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India
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Officer - Lab QA
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Sep 2019 - May 2023
Monitoring laboratory operations and activities are performed in adherence with relevant SOP’s. Ensuring usage of Approved Specifications, Test Methods, Valid Chemicals, Standards and Reagents. Periodic review of Electronic Data, Date and Time verification and Synchronization of all Instruments and Equipment with the help of IT personnel. Verifying of QC Documents which include Test reports of Raw Materials, Packaging Materials, In-process, Pack Finished along with COA, Stability Study reports along with STF, Calibration, Preventive maintenance, Volumetric Solutions. Approval of analytical data, generation and printing of COA in LIMS and ensure that the COA is attached with the compiled report. Verifying reconciliation of Software data files, software control activities and audit trails reviewed by QC Reviewer. To apply, develop and maintain Quality Assurance practices, which will enable the Laboratory to meet and exceed, desired quality standards of regulatory. Ensuring usage of Approved Specifications, Test Methods, Valid Chemicals, Standards and Reagents. Review of QC Documents which include Test reports of Raw Materials, Packaging Materials, In-process, Pack Finished along with COA, Stability Study reports along with STF, Calibration, Preventive maintenance, Volumetric Solutions. Assigning Investigation number and Issuance of investigation form to the Quality Control personnel for the laboratory incidence. To review investigation of Out of Specifications Test results, Out of Trend result and other Quality relevant incidents and non-conformance of Laboratory. Review of Stability Protocol, Stability Samples Charging and Pullout Activities, Temperature and Humidity Records of Stability Chambers. Review of Empower System Audit Trail and Message Center Data for Interrupted sample set and unprocessed channels. Show less
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Medispray Laboratories Private Limited
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India
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Associate - Lab QA
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Jun 2018 - Sep 2019
Ensuring usage of Approved Specifications, Test Methods, Valid Chemicals, Standards and Reagents. Periodic review of Electronic Data, Date and Time verification and Synchronization of all Instruments and Equipment with the help of IT personnel. Ensuring usage of Approved Specifications, Test Methods, Valid Chemicals, Standards and Reagents. Review of QC Documents which include Test reports of Raw Materials, Packaging Materials, In-process, Pack Finished along with COA, Stability Study reports along with STF, Calibration, Preventive maintenance, Volumetric Solutions. Show less
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Indoco Remedies Ltd.
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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May 2017 - Jun 2018
To Perform Daily Analytical Balance & pH Meter Calibration.Analysis of in-process, Stability and finished samples with online documentation and calculation sheet completion.Preparation of Standard Solution, Sample Solution, Mobile Phase as per specification.Tests are perform on various Instrument like Assay by UV & HPLC, Identification by UV,IR & HPLC, Particulate Matter by LPC as per standard procedure.Generate the Certificate Of Analysis on Oasis-LIMS.
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Oct 2016 - Apr 2017
Analysis of In-Process & Finished Product Samples.Calibration of pH Meter & Analytical Balance on Daily & Monthly basis.
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Education
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Gramonnati Mandals Arts, Science & Commerce College, Narayangaon, Junnar, Pune
Master's degree, M.Sc (Organic Chemistry) -
PDEA's Annasaheb Waghire College , Otur, Junnar, Pune
BSc - Bachelor of Science, Chemistry