Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Sr. Audit Specialist
Job ID R0000030352 , IndiaThe Senior Audit Specialist will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of complex Sponsor Audits and Regulatory Inspections. They have the authority and decision-making responsibility to drive Parexel departments’ and Project teams’ Sponsor Audit and Regulatory Inspection preparation activities. Will exhibit a high degree of flexibility and initiative, make decisions during audits in line with Parexel’s QMS, demonstrate the ability to follow up on multiple tasks and projects, and ensure that audits and inspections are hosted with a high degree of expertise and quality.
Liaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, other Quality departments throughout the lifecycle of an SAI
- Conduct all preparation meetings, assign tasks with other internal departments, review all material to be presented and gather necessary information on Sponsor confidentiality agreement documentation.
- Initiate planning process(es), e.g., project plans with deadlines and milestones, tomanage an SAI effectively and seamlessly
- Ensure SAIs are performed to a high degree of client satisfaction and regulatory requirement
- Build, develop, and maintain good working relationships with internal and external customer groups
- Determine most appropriate setting to host an SAI, based upon requirements
- Actively support the host throughout aSAI , as applicable
- Support Non-Parexel-facility audits and inspections, e.g. investigator sites, supplier sites, investigator sites, sponsor offices, as applicable
-Ensure that Technical Enterprise Tools e.g., extranet, PMED, PMEX and Microsoft Teams are set up correctly, are tested and tailored to the Sponsors specific requirements
- Summarize quality events arising from sponsor audits and other related activities, as requested.
- Enter SAI information into the Parexel eQMS and provide follow up on outcomes, as needed.
- With First Time Quality – ensure that information is added and relayed effectively and correctly
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