Sudhir Patel

• Participated in preparations for regulatory inspections, including reviewing Inspection Readiness Plans, Mock Inspections, and risk-based management program inspection quality events
• Participated in audits of the various quality elements to ensure compliance to GCP/GCLP, industry best practices and guidance
• Handling of regulatory Queries/QMS
• Plan and monitor Non-Routine activities
• Look all kind of Qualifications, Validations, Stability Studies analysis in the Lab
• Participate all kind of lab investigation
• Escalate deviations, OOS/OOT
• Provide training to Subordinates, juniors on instruments and SOP

• Leading a team of analyst and monitoring work related to commercial, Exhibit batches and stability section
• Responsible for Initiation, Execution and Approval of all incidence, investigation, file notes, ratification, OOS, OOT, Change control Deviation CAPA
• Responsible for preparation and review of specification, protocol, report, standard operating procedure and AWR for finished product, In process analysis and stability analysis
• Responsible to ensure compliance to GLP, Health, Safety and Environment requirement
• Ensures Compliance & implementation of quality systems

• plan and Handling of regulatory Queries/QMS .
• Plan and monitor Non-Routine activities.
• Look all kind of Qualifications, Validations,Stability Studies analysis in the Lab. Prepare and review stability protocol and report.
• Participate all kind of lab investigation.
• Escalate deviations, OOS/OOT. Review Stability summary report.
• Provide training to Subordinates, juniors on instruments and SOP. Monitor calibration schedule of analytical instruments and reports, Review analytical data.

Maintained laboratory equipment according to manufacturer's instructions while adhering to safety guidelines

• Stability and Drug substances analysis
• To analyze Stability samples, raw materials as well as finished product
• Handling instruments like Karl Fischer, HPLC, and UPLC, Dissolution
• Conduct analysis as per Monographs USP, BP, IP, JP & as per In-house Standard Procedure
• Familiar with modern software such as Empower3, Tiamo, Trackwise, LIMS, EDMS & Docspace
• Maintained schedule of class assignments to meet deadlines
• Worked with cross-functional teams to achieve goals
• Maintained updated knowledge through continuing education and advanced training

• Method validation of sample by using potentiometer, HPLC and GC
• To analyze raw material & Finished Product
• Requirement checking of all samples
• Taking inquiries of analysis of samples coming from other parties
• Handling instruments like Karl Fischer, Polarimeter, IR spectrometer, UV Surface Area Analyzer Potentiometer HPLC, GC, UPLC
• Conduct analysis per Monographs USP, BP, IP, JP & as per In-house Standard Procedure
• Ensured that all validations were completed within established timelines

• Analyze Minerals such as Iron ore, Dolomite ore, Manganese Ore, Coal, Coke, Quartz etc
• According to laid down standard test procedure
• Supervising of sampling, crushing, loading, unloading of Minerals ore at various sites