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Documentum Validation Consultant
The candidate should have experience in developing validation project plan, functional requirements, operational qualification, installation qualification and traceability matrix for Documentum Compliance Manager (DCM) and Documentum Submission Manager (DSM).
The role will also involve performing validation as per FDA/GxP and 21CFR11 requirements . This would include preparing all documentation that would be required for FDA submission and audit.
Desired Skills and Qualifications:
- Ability to take and perform routine validation, quality assurance, and other related job assignments as may be necessary for execution of the project.
- Experience in development of IQ, OQ, PQ, Standard Operations Procedures, and Summary documents.
- Experience in execution of IQ and OQ protocols for systems.
- B.S. or B.A. degree in engineering, science or related fields.
- At least 2 years experience in validation for Pharmaceutical or Healthcare industries
- Working knowledge of FDA GMPs, FDA guidelines, European guidelines and other regulatory requirements.
- Effective written and oral communication skills.
