Parita Patel

Associate Director, Quality Assurance @PharPoint Research, Inc.

Durham, NC, US

Provide consultation and assist with decisions as it relates to the company and departmental QA strategy and departmental goals-Generate, approve and implement external and internal audit plans and processes-Organize and conduct internal audits in accordance with the internal audit schedule-Coordinate and host Sponsor Audits; manage and implement responses to audit observations-Plan, schedule, conduct and report Investigator Site Audits, Trial Master File (TMF) audits and vendor audits-Coordinate and assist in Regulatory Inspections; assist with coordinating and implementing responses to Inspection observations-Develop and maintain ongoing key QA compliance metrics observed from quality processes, audits and Quality Events-Provide QA support, guidance and management of Quality Events, Corrective and Preventive Action (CAPA) Plans and deviations-Provide ongoing QA support and guidance to Operations-Serve as the QA Lead and primary QA contact for assigned projects/clients. Attend and participate in Sponsor and internal project-specific meetings periodically-Generate, review and revise SOPs and QA documents-Complete and review QA-related components on RFIs, proposals and bids-Act as line manager for QA staff and oversee the development of junior-level QA staff-Provide training to junior-level QA staff-Provide support and adhere to all aspects of PharPoint\'s QMS-Review and ensure compliance with PharPoint\'s data integrity and business ethics requirements-Perform all other related duties as assigned.

The University of North Carolina at Chapel Hill

Bachelor of Arts (B.A.), Public Policy with Health Policy Concentration