Validation Engineer/Quality Engineer

Company:Magine Healthcare Solutions LLC
Healthcare & Community
Job Category:
Healthcare & Community
Employment Type:Contract

Job Description:

Key Activities/Responsibilities
• Maintain a list of all computerized systems that are used in the manufacture of pharmaceutical product.
• Assure 21 CFR Part 11 pre- and post-assessments are performed on all systems.
• Assure that computerized systems are released to production in accordance with regional and local procedures.
• Review and approve validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts and discrepancies.
• Assure that computerized systems are in the requalification program and are part of the program for security access review.
• Provide guidance to project teams on the deliverables required as part of the validation package.
• Assure that all computerized systems are compliant with regulatory guidance's, including 21 CFR Part 11 and Data Integrity. 

Company Info

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