 Clinical: Clinical studies Phase I-IV, Bioequivalence, Data Management, Project Management, Monitoring, Archive/Document Management etc. Regulatory Affairs: e CTD, Regulatory dossier and SOP audits, Drug regulatory environment, communications with regulatory authorities and CAPA submissions. IT Validation: validation of computerised systems for clinical and vendor audits Risk-Based Approach in Audit and Compliance, including trend analysis and strategy setting, escalation and Serious Breach internal review Well versed with GCP, GMP, GLP,GXP etc Clinical Trials management GMP auditor Regulatory Affairs auditor Bioequivalence Study management  Quality Assurance pharmaceutical Quality Control pharmaceutical Analytical Instrument (LCMS/MS, HPLC, GC- MS/MS, GC etc) Analytical Software development support Bioanalytical/Clinical monitoring Electronic data review CRO selection and CRO qualification Bioanalytical/clinical third party data review

•Handling the Analytical and Quality assurance department consist of 8 to 10 staff.•Day to day activity planning in Analytical department to support synthetic research department.•Carry out Method development and validation in API and Intermediate.•Preparations of IQ, OQ, PQ documents for analytical instruments.( HPLC, GC, IR,UV etc)•SOP preparation for Analytical department.•Preparation Analytical development report of ARD. Protocol preparation for method transfer to plant QC.•Trouble shooting for Analytical Instruments.

•Supporting the selection and evaluation of new proposed CROs for BA/BE studies on factors such as compliance to the regulatory requirements, facility, resources and infrastructure of CROs.•Completing the outsourced BA/BE projects on time at CROs as per specified timelines and with compliance.•Filing of BA/BE study reports received from various CROs and ensuring proper documentation.•Ensuring adherence to set timelines, plans, GLP norms and regulatory requirements (e.g. ICH, EDQM, US FDA) at current CROs by analyzing and monitoring bio-analytical activities.•Imparting technical guidance to bio-analytical activities for various projects of BA/BE and on various aspects for timely availability of BA/BE report.•Analyzing and evaluating study analytical method for proposed BA/BE projects.•Assessing existing method validation and method development activities as per regulatory compliance.•Rendering troubleshooting support in Analytical and Bio-analytical activities at CRO.•Co-ordinating for the implementation of corrective action plan and preventive measures or independently conducts audit and accompanying the client at the time of Audit of CRO for BA/BE studies.•Ensuring timely preparation of the audit report of CROs and coordinates for compliance of non-complying observations.•Giving inputs for evaluation of final BA/BE reports received for particular projects.•Defining annual performance goals for the team, monitoring and supporting achievement of goals and provides constructive feedback and counseling support to team to improve performance.•Organizing periodic audits at current CROs to ensure authentic and correct BA/BE data

•Assessing and executing novel automation, separation and detection techniques for quantitative bio-analysis and participate in Writing protocols, SOP preparation, reviewing data, etc.•Monitoring the bio analytical department.•Developing and validating LCMS-MS methodology for the quantitation of drugs/metabolites in biological fluids in humans Protocol reviewing.•Monitoring clinical phase BE studies and statistical analysis

Assessing and executing novel automation, separation and detection techniques for quantitative bio-analysis and participate in Writing protocols, SOP preparation, reviewing data, etc.•Monitoring the bio analytical department.•Developing and validating LCMS-MS methodology for the quantitation of drugs/metabolites in biological fluids in humans Protocol reviewing.•Monitoring clinical phase BE studies and statistical analysis

Analysis of Finished product Handling HPLC ,GC,Dissolutuion,UV Instrument Wet analysis

Routine analysis of Finished product Analysis of Stability study sample and Raw material analysis Handling HPLC ,GC,Dissolutuion,UV Instrument Wet analysis

Routine analysis of Chemical and packaging material analysis.Handling Analytical instrument UV spectrophotometer,IR spectrophotometer, Atomic absorption spectrophotometer,Polarogarph,Autotirator

Analysis of Finished product