[Outsource:53450] Required: Quality Validation Analyst

Kindly Send Resumes to adem@vertigonconsulting.com 

 

Position: Quality Validation Analyst

Location: Andover, MA

Duration: 6+ months

 

Locals or nearby Face to face must

 

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

 

Qualifications:

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

 

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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