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GxP Systems Specialist

Company Name:
Opus Scientific
GxP Systems Specialist New Albany, OH
Opus Scientific has a great opportunity for an experienced GxP Systems Specialist to work at a large innovative manufacturing company.
Responsibilities
Generate, review and remediate computer system validation protocols to ensure company is meeting regulatory requirements.
Maintain system inventory of Gxp Systems use for production and support.
Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, Test Case Scenarios.
Develop department SOPs and provide SOP review for new systems.
Perform Validation/Part 11 Assessments for new and existing computer systems.
Perform scheduled reviews of existing GxP Systems and define remediation plans for non-conformances.
Maintain GxP Systems log and update as necessary.
Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices as well as latest regulatory guidance's and regulatory updates.
Identify, communicate and escalate project and compliance related issues.
Conduct validation related training.
Qualifications
Associates degree in a related field
Minimum 2 years experience working directly with computer system projects/implementations
Project management practices and techniques experience
Familiarity with software development life cycle, GAMP5 approach to software implementation
Knowledge of pharmaceutical principles, practices and applications
Proficiency with computer hardware and Enterprise software applications (MS Office, MS Project, MS Visio)
Principles and practices of computer validation and qualification knowledge
Strong Business English for documentation including spelling, grammar, and punctuation
Salary
Commensurate with Experience
If you meet the qualifications and are interested in hearing more about this opportunity, please submit your resume to and include GxP Systems Specialist as the email subject line.

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