[Outsource:57296] Required: QA Validation Consultant

Kindly Send Resumes to adem@vertigonconsulting.com 

 

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: adem@vertigonconsulting.com
URL: www.vertigonconsulting.com

IM:  adem_vertigon@yahoo.com

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