Dear Partner,

Here is an urgent requirement from caresoft.
Most of our qualified submissions lead to immediate client interview.
Therefore, please do not submit Candidates who are close to confirmation /
Please respond with Consultant's:-
*Present Location:*
*Contact number No. with Email ID:*
*Location: Spring Field, NJ*

*Duration 10-12 months*

Rate :Open



Supports the design and maintenance of software, hardware and instrument
development projects with responsibility for assuring quality in relation to
21 CFR Part 11 and other compliance requirements within the sponsoring

60 percent - Advisor to Project Teams
*Participates as a subject matter expert on 21 CFR Part 11 and other
compliance/quality related activities* that are part of good system
development. Is responsible for authoring portions of the quality
documentation creation as per the departmental level SOPs and practices.
Assures that project teams are fully versed on the requirements of systems
in all lifecycle phases to be in a state of sustained compliance and imbeds
those requirements into new system development projects as well as ongoing
maintenance for legacy systems.

20 percent - Internal QC Review
Has the responsibility to help develop *and document compliance strategy
solutions* in the 21 CFR Part 11 Compliance Strategy Document. In some
cases, will take ownership of assessment documents within the sponsoring
department and will transition these assessments, with the help of business
and technical subject matter experts, into workable Compliance Strategy
Documents. In situations where the business owner will write the CSD, the
Quality Control Manager will partner with that person and will sign the CSD
indicating that they approve of the strategy for meeting the Assessment

20 percent- Controls Vendor Audits
Attends or sends appropriate delegation to all vendor audits (system or
service vendors) for the sponsoring department to represent the *21 CFR Part
11 and other compliance related requirements for that department based on
its SOPs and/or practices.*

*Thanks & Regards,
Ankur Nigam,
Caresoft Inc.  40 Brunswick Ave. Suite 205 , Edison NJ 08817      URL :
Phone 732-993-5362        Email   : [EMAIL PROTECTED]       gmail   :
yahoo : ankurnigam2009*

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