NIB Noida, Nov 2012-March 2014
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Responsible for Rapid and ELISA batch testing of HCV, HIV and HBsAg.
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Panel characterization for HCV, HIV and HBsAg.
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Preparation of SOPs.
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Preparation of batch reports.
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Follow up and implementation of SOPs.
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Responsible for carrying out NABL Audits.
Alere Medical Pvt. Ltd.(managed By Abbott Laboratories) 01 April 2014 – 01 June 2018
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Responsible for in process audits, System Audits, Management review meeting.
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Verification and implementation of various counter measures and corrective actions taken for in process non conformities observed in process.
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Review and revision of SOPs, MFR as per change in process.
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Auditing for Standard Operating Procedures.
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Initiation of QI/CAPA, Change request, keeping a track on QIs/CAPAs, change control and timely completion of QIs/CAPAs.
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Investigation, root cause, impact assessment, risk assessment of QIs and CAPAs.
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Preparation and implementation of manufacturing procedures, SOPs and STPs of in-process production batches of Rapid, ELISA and Urocolor as per the requirement of
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Good manufacturing practices.
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Monitoring and supervising of production in-process for reducing the risk of substandard quality.
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Check performance and quality of in-process production batches of Rapid, ELISA and Urocolor.
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Ensure and confirm product specification as per compliance during production operations.
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Training and re-training of documents to machine operators / team leaders / line supervisors.
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Check on batch manufacturing record preparation and control on occurrence of errors in record filling
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Familiar and error free handling of IPC equipment like ELISA reader, washer, pH meter, conductivity meter etc. which is required for testing of in-process production batches.
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Trouble shooting of quality issues of in-process batch for Rapid test and ELISA reagents and Urocolor.
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In-process evaluation and check of each component and reagents of Rapid test in accordance to nitrocellulose membrane of every lot of every product.