As a Lead QA for CAPA Management:-Review the CAPA plans submitted by the Operations team and approve or reject as acceptable ensuring that the plans are adequate to mitigate the root cause identified during the investigation.-Determine the severity of the findings and assess the impact and root cause -Co-ordinate with the Project Lead, Clinical Lead and CRAs for investigation of Major /Critical findings-Review the confirmation of actions and evidence (where required) and provide final approval for CAPA.-Review and finalize the CAPA drafted for the Audit findings post Customer or regulatory Audit at global sites prior to sharing the actions with Sponsor/ Regulatory Authority.-To determine whether effectiveness check is required for a CAPA plan and follow-up with the team.-To track the Investigation and CAPA plans in TrackWise® and follow up with the CAPA owners to ensure timely closure of CAPA and submission of response to Sponsor.-To update the Investigation summary and CAPA plans in TrackWise® from the time of initiation till closure of the event.

-Responsible for overseeing overall quality aspects in the facility and maintain the quality systems within the department-To provide QA and regulatory support to Glenmark R & D and Medical affairs team in planning and scheduling of Clinical Studies/ Bio-availability- Bioequivalence studies by outsourcing the studies to compliant CROs and implementing the QA program. -Review documents such as Study Protocol, Informed Consent forms, EC documents, Adverse Event reporting and ensure compliance to GCP and applicable regulatory requirements.-Perform quality review of study data and reports to assure compliance with regulatory requirements prior to submission to the regulatory agencies.-Plan and conduct pre-approval and routine external vendor audits.-Ensure compliance with 21 CFR Part 11 requirements and GxP standards through integrated quality reviews of all computer system validation processes, procedures and documentation.-Liaise with the R & D Department of Glenmark and CROs for planning and scheduling of Bio-studies -Prepare and submit BA/BE NOC documents as per DCG(I) requirements/checklist. -Design and develop training programs.-Facilitation of continuous improvement through management of corrective and prevention actions (CAPA)-SOP Management and Document Control

-To undertake site audits for CROs -To Plan and allocate projects within the QA department and meet timelines -To perform quality audits of the clinical studies and ensuring compliance to Ethics approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), principles of GLP and Standard -Operating Procedure (SOPs) and ensure that the integrity of the data is maintained to the highest level possible. -Perform QA review of the IT systems (Software validation documents, SOPs, change controls) within the department to ensure compliance to the rules of FDA 21 CFR Part 11-Electronic Records; Electronic Signatures (WinNonlin, SAS, Study Data management software, Analyst Software for LC-MS-MS)-To audit Central Labs, IEC operations, Translators and other vendors/ service providers. -To audit EC submissions and Adverse event documentation, adverse event reporting to Ethics committee and regulatory authorities -To audit Bio-analytical data and report generated during the course of the BA/BE study to ensure compliance with regulatory guidelines and SOPs.-To develop, execute and maintain audit schedules according to the project requirements-To co-ordinate and conduct training programs.-Review regulatory submissions and Query Management for the queries received from Regulatory Agencies, if any.-Periodically submit to management written status reports, noting any problems and the corrective actions taken.-Escort regulatory inspectors/ consultant auditors during inspections and provide post-inspection follow-up information as requested. -Provide QA Support to the Medical Department of Wockhardt for monitoring/ auditing Clinical trials outsourced to the CROs and perform review of the documents.-To work towards Harmonization of systems & procedures through management of preventive and corrective actions (CAPA)

-Actively involved in designing the layout for the setup of the bioequivalence center and developed Quality systems for the start-up facility.-Audit the bio-studies and ensure compliance to IEC approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), principles of GLP and in-house Standard Operating Procedure (SOPs)-Conducting quality and compliance check of studies out-sourced to CROs.

As a QA personnel, responsible forConducting audits of the system, studies and facility in compliance to the GCP, GLP and other applicable regulations and In-house SOPsReporting the findings to the management at regular intervals noting any problems and the corrective actions takenAssisting in the preparation and control of quality procedures and checklists for clinical studiesPrior to this designation, was responsible for managing and guiding all the activities of bioanalytical support (method development, method validation and Clinical Study Samples) to all clinical studies conducted as per GLP regulations