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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] -- You received this message because you are subscribed to the Google Groups "Oracle-Projects" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/oracle-projects?hl=en.
