Hi,
Hope you are doing well !!
This is Harish From USG.I
have an Urgent Requirement for Validation Lead . I hope your resume fits
for the below position. Kindly let me know your interest and also required
your updated resume. Please feel free to reach me any
time.
*Role: Validation Lead*
*Location:* * Indianapolis IN*
*Duration: 16 months*
*Experience: * 7 Years +
*JD*
*Technical/Functional Skills*
1. Regulatory Compliance and Computer System Validation Consulting
Capabilities
2. Technical Authoring Skills with mastery over tool (MS Office
Suite, Adobe)
*Experience Required*
*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
*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 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
*Generic Managerial Skills*
· 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.
Harish Karnala
United Software Group Inc..
565 Metro Place South. Suite # 110
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Dublin, OH 43017
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Direct Number : +1 614-408 1549
Board Number : 614-495-9222 EXT. 622
Fax: 1-866-764-1148
[email protected]
www.usgrpinc.com
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