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.