Thanu shree

I am working as a research associate at Recipharm company.

I am well versed in Good Laboratory Practice (GLP) and Good Documentation Practice (GDP), ensuring compliance with industry standards. Additionally, I have a solid understanding of errata and Laboratory Investigation Reports (LIR), which aids in maintaining accuracy and reliability in laboratory documentation and investigation.

Well versed in Gap Assessment analysis and handling of change controls, Deviations, CAPA, Investigations, OOS, OOT, OOC and other system documents.

• Operated and performed preventative maintenance and calibration on laboratory equipment and instruments.
• Prepared reagents and solutions following standard laboratory formulas and procedures.
• I have gained substantial hands-on experience with a variety of analytical instruments and techniques. I am skilled in operating UV spectrophotometry, pH meter, Karl Fischer Titration (KF), High-performance liquid chromatography and dissolution apparatus.
• Preparing of Master schedule, Master Preventive maintenance schedule, Requalification schedule, SOP index, pharmacopeial complaints and equipment index.
• Wide exposure to Customer Audits and coordinated audits, well versed providing response to audit observations. Faced USFDA audit, QP Audit, ANVISA, CGMP certification audit, ISO, Health Canada, Central Drug Standard Control Organization (CDSCO) and European Medicines Agency (EMA), customer audits like Biocon, Sun Pharma, Aurigene, Biohaven, and J & J.
• Generating of Analyst validation COA (Analyst test to be performed according to the specifications).
• Good hands in handling of Nichelon (Training software), QAMS (Quality Management system software) and DMS (Data management system software)
• To ensure that analytical work is carried out in accordance with cGLP compliance,Compendia and Regulatory requirements.
• Performed audits for GMP compliance and implemented changes to quality systems to exceed minimum regulatory requirements.
• To ensure that all the data/documents generated meet the quality norms as per quality/regulatory requirements.
• Conducted and carried out audits at multiple locations to verify all quality, regulatory and safety activities were performed in accordance with company policies, processes, operations and Regulatory requirements.
• Execute audits, including unannounced visits, and follow up with reporting and advice on necessary corrective actions.
• Support the deviation handling system by handling deviation and executions investigations Analytical development Department.
• Implemented and revised standard operating procedures (SOPs), STPs and other Documentation Systems, Routed and released promotional materials to ensure compliance with regulatory submissions and requirements.
• Ensuring timely scheduled reviews of documents through appropriate individuals as required.
• Excellent verbal and written communication skills, including a consistent ability to develop and maintain a positive team-oriented environment.
• Handling of Backup, Audit trail of Standalone and Networking Systems, Qualification of instruments.
• Analytical Review of Raw materials, In-Process Products, finished products, Stability samples, Packaging materials and Calibration Data.
• Conduct periodic Quality Management Review (QMR) meetings with the cross functional teams.

• Executing daily and monthly calibrations of the instrument.
• Periodic checking of all logbooks of laboratory.
• Coordinating with external engineer for instrument equipment breakdown.
• Completed internship program and worked in Chemical section in Quality Control Department from Karnataka Antibiotics and pharmaceuticals limited.
• Participated in lab meetings and project presentations.