Lead Validation Engineer

Implementation partner : TCS location : Indianapolis, IN (Day One Onsite) Job Description / Skills : Lead Validation Engineer ? 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 within the Sales and Marketing and / or Medical / Regulatory business. ? Good understanding of industry regulations (FDA and other regulatory agencies world-wide) ? 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. ? Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable. ? Experience of working in virtual teams across different cultures and geographies ? Experience of working with cloud-based technologies is desired.