Previous Job
Previous
Computer System Validation Lead
Ref No.: 18-55677
Location: Indianapolis, Indiana
Start Date: 08/03/2018
 1.        Regulatory Compliance and Computer System Validation Consulting Capabilities
2.        Technical Authoring Skills with mastery over tool (MS Office Suite, Adobe)
 
Required
·        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)
·        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, Macromedia tools, Robohelp and so on)

Desired
·        Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable
·        Experience as a Testing Lead/Tester and knowledge of Testing tools
·        Experience of working in virtual teams across different cultures and geographies
·        Experience of working with cloud based technologies is desired
International work experience is desirable but not required
·        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 for 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 team to achieve defined milestones and key objectives
·        Ensure external and internal process compliance of the team at all times