*Please share the resume with *sw...@ennovace.com

*Quality Validation EngineerLocation: Woodcliff Lake, NJ*

*Duration: 6+*


*Interview mode: Phone hire then F2F*




*REQUIRED SKILLS                             *

*•BA/BS degree preferred or equivalent pharmaceutical industry experience
required.*

*•3-5 years experience in writing GxP computer systems validation
documentation in a pharmaceutical or research environment. *

*•Must have working experience in 21 CFR Part 11*

•Must be able to work with minimal supervision

•Computer skills including MS Word, Excel, PowerPoint and Lotus Notes

•Must be able to function in a team environment

•Excellent written skills

•Excellent communication and interpersonal skills



*Overview of responsibilities: *

*•Provide technical writing support for IT Quality Management activities*

•As a document coordinator, organize, standardize and maintain workflow of
documents for validation documentation structure including change control

•Provide technical writing abilities for developing controlled documents
involved with new computer systems implementations, change controls and
other deliverables of computer systems validation.

*•Develop documentation to capture User Requirements, Functional
Requirements, Design Documents, IQ/OQ/PQ Test Scripts, Validation Plans and
Summary reports, system manuals, SOPs, etc. in an* efficient manner.

•*Must have good working knowledge of 21 CFR Part 11.*

*•Maintain reporting data on Key Performance Indicators (KPIs) regarding
Computer System Validation Statistics*

•Support communication between the members of IT and other departments.


Thanks

Regards

*Swami A*
Technical Recruiter



*Ennovace Inc*

Ph: 214-541-9378

F: 972-913-8300



sw...@ennovace.com



www.ennovace.com

1801 S O'connor Rd

Irving TX 75061

In my absence please contact Steven at ste...@ennovace.com (214-541-9081)

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