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.
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