TATA Consulting Services

Computer System Validation

Indianapolis, IN, US

Remote
Full-time
$75k–$80k/year
6 days ago
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Summary

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. Salary Range: $75,000-$80,000 a year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1

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