Role: Computer System Validation Consultant
Location: Indianapolis, IN (Onsite)
Job Type: Full Time
Job Description
Must Have Technical/Functional Skills
• Minimum of 5 years’ experience as a Computer System Validation Consultant in a regulated environment (preferably Pharma) and must have played a lead role (able to work independently with minimal guidance).
• Worked in a Pharmaceutical company as QA/QC.
• Good understanding of industry regulations, GxP compliance (FDA and other regulatory agencies world-wide)
• Excellent communication skills with strong command over written and spoken English.
• Technical Writing experience and expertise with relevant tools (MS Office Suite, Adobe documentation Suite)
• Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable.
• Experience of working in virtual teams across different cultures and geographies
Roles & Responsibilities
• Play a client facing Compliance Lead role in projects, programs, and support work.
• Provide consulting and guidance on quality and compliance needs to IT project teams and enable them to achieve compliance using a risk-based right-sizing approach.
• Take ownership of assigned project/program/support responsibilities and deliver to committed timelines.
• Meet quality expectations as per defined contractual obligations to the client.
• Monitor, guide and drive off-site teams to achieve defined milestones and key objectives.
• Always ensure external and internal process compliance of the team
Generic Managerial Skills, If any
• Resource should be quick learner and self-driven; capable of working with client partners to meet strategic Objectives
• Resource must be able to identify, mentor and hone talent to build leaders from within a team.
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