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Job Information
Job title

21 CFR Part 11 QA Validation (#4330837)

Company Izar Associates, Inc.
Wage Not specified
Location United States, New Jersey, Piscataway
Employment type Contract to Perm
Education High School
Year Experience 4 - 5 Years of Practical Experience
Travel Not Specified
Published on 5/27/2005
Description
Role Description: * Review current SOPs and work instructions for predicate rule compliance, security requirements, disaster recovery, and data retention plans* Support computer system validation projects in conjunction with system owners for analytical laboratory and manufacturing systems* Conduct reviews of computer system validation documentation including but not limited to compliance assessments, corrective action plans, validation plans, user requirements, configuration specifications, protocols (IQ/OQ/PQ), test summary logs, and validation summary reports* Request corrections to validation documentation as required* Monitor compliance with the provisions of applicable computer system validation SOPs* Develop documentation as required for assigned projects, including SOPs, guidelines, summaries and other correspondence* Consult on computer system validation / 21 CFR Part 11 questions and issues

Requirements:

* B.S. Degree in life science, computer science, or related field (or equivalent experience)* Demonstrated experience in performing Quality Assurance review of validation documentation* Knowledge of Quality Assurance and experience in a Pharmaceutical GMP environment* cGMP and 21 CFR Part 11 Electronic Records/Electronic Signatures regulations training and knowledge* Microsoft Office applications proficiency* Superior oral and written communication skillsDesired skills: * M.S. Degree (or higher) in life science, computer science, or related field (or equivalent experience)* cGMP auditing experience.Extensive knowledge of cGMP, GLP and GCP and be able to apply to IT projects.Prior experience in training in a software quality system model (ISO 9000-3, IEEE, or CMM) is highly desirable.


You may apply directly with ?id=4330837df-tc

Experience/Skills
See Above

Other desired skills:
21 CFR Part 11 QA Validation (#4330837)
This job has expired.