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.