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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