Hello Partner*,*


Hope you are doing well,



This side Akash and I have a urgent requirement for my client, Please find
the job details below and let me know your interest for the same-



*Job Title:* *Quality Analyst with CFR*

*Job ID:* *2016-6966*

*Job Location:* *Skillman, NJ or Ft. Washington, MD*



*Only EAD-GC/GC/Citizens*



*Job Responsibilities:*

·         Author relevant validation documentation (e.g. Master Plans, Test
Scripts, Templates, etc.), as defined by the Client's IT SDLC methodology.

·         Execute all relevant validation protocols and test procedures, as
defined by the Clients' IT SDLC methodology

·         Develop validation documentation as required (e.g.
specifications, user requirements, plans, protocols, procedures,
traceability matrix, error/defect reports, etc. ).

·         Execute qualification protocols as required.

·         Prepare reports of executed protocols for review by QA.

·         Track and resolve exceptions during qualification activities.

·         Proactively resolve conflicts between compliance requirements and
project/business constraints.

·         Co-ordinate validation activities with IT, Business, QA
activities.

·         Participate in SCRUM event



*Skills and Experience Required:*

Technical Skills:

·         Solid understanding of Computer System Validation

·         Strong knowledge of cGMP regulations related to CSV, including 21
CFR Part 11, Part 210, Part 211 and Part 820 is required



*Non-technical Skills:*

·         Must have the ability to make decisions by seeking out and
maintaining trusting and collaborative relationships to meet business needs
and demands

·         Must have the ability to work effectively in a highly matrixed
systems environment

·         Must be a team player with the ability to be an individual
contributor

·         Must have keen attention to detail



*Desired:*

·         Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks

·         Background in testing







*Thanks & Regards,*

Akash Sinha

Kani Solutions
*Phone:* 609-952-6471

*Email*: ak...@kanisol.com

*Gtalk: *akashsinha1...@gmail.com

LinkedIn <https://www.linkedin.com/pub/akash-sinha/b1/a04/57b>

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