Hi Folks,
Hope you're doing great there..!
Please find the requirement given below .Share your profile and details to
the given address.
*Share your Profile at vicky@itscient,com*
*ITS AN FULL TIME PERMANENT JOB OPPORTUNITY .*
*Role :- Validation Lead*
*Location: Indianapolis,IN*
*Duration :- FTE*
*Client : TCS*
*JOB DESCRIPTION *:-
Key skills:-
21 CFR Part 11 / CSV, Regulatory IT Compliance ( CSV, ERES Compliance),
Computer System Validation (CSV), Validation, Technical Writing, Quality
Lead
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
• 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.
*SKILL SETS SUMMARY* :-
Full Name
Contact Number
Email ID
Current location
Salary
Relocation Yes /No
Work Authorization in USA
Total Years of Exp
Skype ID
LinkedIn Id
Any Interview In Pipeline ?
Any Offer In Pipeline?
Availability for Phone Interview & Skype
2 TIME SLOTS FOR INTERVIEW
//
Start Date
*Chitranjan Kumar Singh*
*IT–SCIENT LLC, Fremont, CA, USA ll Phone USA : (510) 516-7833 ****EMAIL: *
*chitranja...@itscient.com* <chitranja...@itscient.com>
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