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GxP compliance auditor/Systems validation specialist

Company: Infosys
Location: Basking Ridge
Posted on: June 23, 2022

Job Description:

Domain Consultant - Life Sciences

Infosys's Domain Consulting Group is seeking a Life Sciences Senior Domain Consultant. You will be the leading validation activities for clients and might also be involved handling IT Compliance audits and assurance and supporting external inspections from Regulatory bodies like FDA, MHRA, European Health Commission, Health Canada, etc.Required Qualifications:

  • Candidate must be located within commuting distance of New York/New Jersey/Connecticut area or be willing to relocate to the area. This position may require travel within the US.
  • Bachelor's degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
  • At least 4 years of Information Technology experience.
  • U.S. citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time.
  • Minimum 3 years' experience in operating in a pharmaceutical / life sciences / medical device / health technology company as an IT Quality / GxP compliance auditor or systems validation specialist.
  • Performing on project teams and providing deliverables involving the evaluation of IT quality and GxP issues in an FDA regulated environment.
  • Evaluating IT risk issues, including the use of data and technology to provide greater coverage, targeted precision and insight.
  • Evaluating IT and business controls, including those relevant to GxP, IT quality and 21 CFR Part 11.
  • Understanding of common IT risk domains, including cybersecurity, privacy, disaster recovery, change management and IT operations.
  • Understanding of the software development lifecycle, including expected controls in an FDA regulated environment and associated computer systems validation.
  • Understanding of Corrective and Preventive Action (CAPA) issues management in an FDA regulated environment.
  • Performing assessments to evaluate IT controls, security, SOD, and potential for optimization as well as implementation and/or configuration of ERP products.
  • Having a broad understanding of the system architecture, data flow, and key financial and operational processes within a pharmaceutical, life sciences, CRO, or medical device organization.
  • Experience and desire to work in a management consulting environment that requires regular travel.Preferred Qualifications:
    • Professional compliance certifications like CISA, CRISC, CISSP, ASQ, etc.
    • Knowledge of Agile/Scrum as required for Validation (Certifications like PSM, SAFe Scaled Agilist, PMI ACP are an added advantage).
    • Experience and desire to work in a management consulting environment that requires regular travel.
    • Planning and Co-ordination skills.
    • Good Communication and Analytical skillsAbout Us

      Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.
      Visit to see how Infosys (NYSE: INFY) can help your enterprise navigate your next.EOE/Minority/Female/Veteran/Disabled/Sexual Orientation/Gender Identity/National Origin.

Keywords: Infosys, Newark , GxP compliance auditor/Systems validation specialist, Accounting, Auditing , Basking Ridge, New Jersey

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