Ms. Renu Yadav

NIB Noida, Nov 2012-March 2014

• Responsible for Rapid and ELISA batch testing of HCV, HIV and HBsAg.
• Panel characterization for HCV, HIV and HBsAg.
• Preparation of SOPs.
• Preparation of batch reports.
• Follow up and implementation of SOPs.
• Responsible for carrying out NABL Audits.

• Responsible for in process audits, System Audits, Management review meeting.
• Verification and implementation of various counter measures and corrective actions taken for in process non conformities observed in process.
• Review and revision of SOPs, MFR as per change in process.
• Auditing for Standard Operating Procedures.
• Initiation of QI/CAPA, Change request, keeping a track on QIs/CAPAs, change control and timely completion of QIs/CAPAs.
• Investigation, root cause, impact assessment, risk assessment of QIs and CAPAs.
• Preparation and implementation of manufacturing procedures, SOPs and STPs of in-process production batches of Rapid, ELISA and Urocolor as per the requirement of
• Good manufacturing practices.
• Monitoring and supervising of production in-process for reducing the risk of substandard quality.
• Check performance and quality of in-process production batches of Rapid, ELISA and Urocolor.
• Ensure and confirm product specification as per compliance during production operations.
• Training and re-training of documents to machine operators / team leaders / line supervisors.
• Check on batch manufacturing record preparation and control on occurrence of errors in record filling
• 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.
• Trouble shooting of quality issues of in-process batch for Rapid test and ELISA reagents and Urocolor.
• In-process evaluation and check of each component and reagents of Rapid test in accordance to nitrocellulose membrane of every lot of every product.