Jigna Patel, ASQ-CQA

The Executive Director of Clinical Quality Assurance (CQA) is accountable for overseeing all aspects of Quality Assurance within the CQA Team as part of the overall Quality Organization at Ocular. The Executive Director will set quality objectives, formulate strategic action plans, establish audit protocols and be accountable for overseeing the Quality Management System governing Quality operations. The Executive Director will provide leadership and guidance to personnel within the CQA group and direct support to other critical Functional Areas.

Provide/Handle an oversight to the QA team on a day-to-day activity which includes multiple clinical studies, clinical/commercial manufacturing, technical transfers, due diligence, product releases, Quality Management Systems (Audits, SOPs, training, Deviations, CAPAs, and product complaints) oversight, and GLP non-clinical studies.

Lead the QA team and provide day-to-day QA support to the cross-functional teams QMS, SOPs, Training system Management Drove Regulatory inspection and communications for QA team

• Review, Approve and manage CAPAs, deviations, OOS, OOT, Change controls • Provide training for current GxP practices and SOPs to all employees • Review and Approve internal SOPs, policies, and guidelines/ write QA SOPs • Handle non-routine audits that will include due diligence, for-cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. • Provide extensive support in the deployment of Veeva Quality Docs electronic SOP management system and Compliance Wire Learning management system • Provide support to perform routine Quality Assurance qualification/re-qualification audits for CROs, CMOs, and Investigator sites • Conduct internal audits of internal facilities, data, and clinical study-related activities and processes in GxPs to assure adherence to corporate policies, internal standards/requirements, and compliance with applicable regulatory requirements. • Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.

• Implement Biopharmaceutics Compliance Plan for assigned bioequivalence programs • Conduct and/or assist audits of contract CROs/labs, IRBs and study reports, in order to assess the accuracy and quality of scientific data and ensure GCP compliance of PK/BE testing activities to support regulatory submissions. • Assist in the Development and maintenance of Biopharmaceutics Compliance SOPs and audit tools. • Assist in the development and review of protocols and other study related documents in conjunction with other company sites • Investigate and resolve compliance problems and questions regarding the conduct and reporting of PK/BE studies. • Provide Biopharmaceutics Compliance support for regulatory filings • Assist with SOP and other GCP training for functional areas, as required.

• Ensure that studies are conducted and the data collected in GLP, GCP and GMP compliance with appropriate guidelines, protocol, Standard Operating Procedures and /or other governing factors. • Assist in conducting audits of R&D departments for compliance with regulatory directives and corporate, divisional and departmental policies and procedures with CAPA and risk assessment programs. • Issue timely and accurate audit reports that communicate what was audited and any observations on noncompliance issues related to GCP , and GLP regulations. • Identify opportunities for quality improvements and assist in gaining approval for and implementing quality improvements. • Provide timely and accurate reporting of appropriate measures of quality performance. • Review R&D departmental SOPs for compliance with regulatory directives and Merial quality standards. • Conduct internal and external audits and inspections of Merial and contract facilities to ensure adherence to GCP,GLP requirements. • Provide support to host FDA and EPA regulatory inspections.

• Conduct experiments for analytical methods development/validation for assay of bulk drugs, GCP release materials and finished dosage forms. • Conduct assay testing on raw material, finished and stability products by using UPLC, HPLC and GC,TLC, GCMS. . • Report and troubleshoot data in LIMs.. • Stability and release testing of development products. • Understand and comply with safety, GMPs, GLPs, SOPs, and policies. • Record, evaluate, interpret and summarize technical data. • Develop and review calculation procedures using Microsoft Office Excel. • Document activities in technical notebooks. • Prepare reports, memos or regulatory documents. • Perform peer reviews. • Respond to QA audits. • Conduct regular lab safety inspections.

Worked as an Analytical chemist for Cadbury schweppes in reaserch and development department. Worked on raw materials, finished products and stability samples analysis using HPLC, GC, and FTIR. Characterization and physical properties using wet chemistry techniques. Perfomed Method development, validation and transfer along with routine analysis by following Gxp regulation