Urgent Opening for Validation Analyst in Peapack, NJ / Belgium (short duration travel) with TCS

Hi,

 

Hope you are doing great!!

 

Please see the below job description and share a copy of your consultant's updated resume.

 

Job Title: Validation  Analyst

Location: Peapack, NJ / Belgium (short duration travel)

Duration: 12+ Months

Client: TCS

 

 

Please reply at vishwa.dubey@idctechnologies.com

 

 

Job Description

Key words to search in resume

  • Good understanding of Software Development Life Cycle (SDLC) and Validation life cycle

·         Experience in formulation of as validation master plan, User Requirement Specification (URS), Functional Requirement Specification (FRS), Business Requirement Document (BRD) and Validation Protocals( IQ,PQ & OQ).

 

Technical/Functional Skills - Must Have Skills

  • A Minimum of a Bachelor's degree in sciences/IT
  • Experience in Pharma quality and compliance in IT systems.
  • Demonstrated skills for independently guiding quality and compliance activities fro IT applications in the Pharma industry.
  • Experience with risk based approaches for IT Application development.
  • Good understanding of Software Development Life Cycle (SDLC) and Validation life cycle
  • Experience in formulation of as validation master plan, User Requirement Specification (URS), Functional Requirement Specification (FRS), Business Requirement Document (BRD) and Validation Protocals( IQ,PQ & OQ). Understanding on Life Science domain

·         Understanding on various regulations GxP, 21CFR Part 11and others

 

Roles & Responsibilities

  • Liaison between the technical team and the Users/stakeholders and ensuring effective business use of enterprise systems through requirements gathering, detailed process analysis, validation, system monitoring, troubleshooting, advanced training and project support.
  • Creating Validation Plan
  • Independently provide guidance and be responsible for validation of small projects
  • Responsible for pre-review and post execution review of all the Validation protocols
  • Review of traceability metrics
  • Create Validation summary report
  • Ensure library management of all validation deliverables
  • Responsible for updating current state compliance of IT portfolio.
  • Responsible for follow-up of the review and approval cycle with Quality, Business and IT Team.
  • Experience in HPQC, Trackwise

 

 

Thanks & Regards

 

Vishwa Dubey

Technical Recruiter

IDC Technologies  Inc.

Silicon Valley

1851 McCarthy Blvd.  Suite | 116

Milpitas,  CA 95035

 

Email : vishwa.dubey@idctechnologies.com

Website : www.idctechnologies.com

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