Senior Consultant - Life sciences Domain

Infosys • Indianapolis, IN

111d

About The Position

Infosys is seeking Life Sciences Domain Consultant. As a commissioning and Qualification 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.

Requirements

• Must be located within commuting distance of Indianapolis, IN or willing to relocate.
• Bachelor's degree or foreign equivalent required from an accredited institution.
• At least 4 years of Information Technology experience.
• Strong Quality and compliance experience.
• Experience in project teams providing deliverables.
• Understanding of IT risk domains.
• Experience with OT System commissioning and Qualification.
• Experience with PAS/DCS Qualification.
• High level of understanding of ISA95.
• Experience in stakeholder management.

Nice To Haves

• Knowledge of Agile/Scrum for Validation.
• Planning and Co-ordination skills.

Responsibilities

• Lead validation activities for clients.
• Handle IT Compliance audits and assurance.
• Support external inspections from Regulatory bodies.
• Evaluate IT quality and GxP issues in an FDA regulated environment.
• Evaluate IT risk issues using data and technology.
• Evaluate IT and business controls relevant to GxP, IT quality and 21 CFR Part 11.
• Understand common IT risk domains including cybersecurity, privacy, disaster recovery, change management and IT operations.
• Manage Corrective and Preventive Action (CAPA) issues in an FDA regulated environment.
• Commission and qualify OT Systems.
• Work with MES and QMS (Track wise).
• Perform PAS/DCS Qualification.
• Integrate PAS/DCS with Manufacturing Equipment qualification.
• Manage stakeholders and communicate effectively.

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees