Kindly Send Resumes to adem@vertigonconsulting.com
Position: Quality Validation Analyst
Location: Andover, MA
Duration: 6+ months
Locals or nearby Face to face must
Must Have Pharma exp
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
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