{LOCAL ONLY}:;;;Urgent Requirement :- Validation QA Tester (NJ , 6+Months)..........

Location: 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

 

Swami@ennovace.com

 

www.ennovace.com

1801 S O'connor Rd

Irving TX 75061

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

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Thank you
Regards
Swami A
Sr. Marketer
Ennovace Inc
Ph: 214.541.9378
F: 724.264.5637

swami@ennovace.com

www.ennovace.com
1801 S O'connor Rd
Irving TX 75061

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