Kindly Send Resumes to [email protected]


Position: QA Validation Consultant

Location: Woodcliff Lakes, NJ

Duration: 6 Months contract



*LOCAL CANDIDATES PREFERRED AS THEY MAY NEED TO GO IN PERSON AFTER A
PHONE.  *



*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 (KPI’s) regarding
Computer System Validation Statistics

• Support communication between the members of IT and other departments



Thanks & Regards

Adem
Technical Recruiter
Vertigon Consulting
Phone: 201-786-2670
Fax: 732-398-0506
Email: [email protected]
URL: www.vertigonconsulting.com

IM:  [email protected]

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