Job Description

The Sr GxP Systems Analyst will support the management of GxP applications throughout the system lifecycle. This includes but is not limited to day-to-day troubleshooting, applications support, system administration, solution configuration, managing customizations, data security, data integrity GxP compliance, and CSV support.

Additionally, this position is a business partner to multiple business functions responsible for problem resolution. The role may also interact with external service providers, collaborating and aligning on general management of GXP applications.

The incumbent in this position must be able to research and resolve difficult and complex problems.

System Administration and Support

 Support the system administration of GxP applications in the our clients environment, including but not limited to Master Control, Trackwise Digital, Tracelink, Part 11 DocuSign, Veeva, Argus.

 Support the analysis, design, development and installation of GxP applications in accordance with established SOPs.

 GxP Computer System administration, escalation point, and maintenance support.

 Prepare, review, and approve GxP Computerized Systems Validation lifecycle documents as an IT GxP SME.

 Demonstrate the ability to work systematically and logically to analyze situations, resolve problems, identify causes, and anticipate implications.

 Support analysis, resolution of Incident Management and technical investigations.

 Follow companys change management process to comply with ITGC policies.

Business-Technology Process Management

 Functional and technical requirement gathering, gap analysis and documentation for GXP applications.

 Documents and assist users in defining business requirements, process maps, and use cases

 Organize and execute analysis, design/configuration, implementation and delivery of GxP Applications.

 Actively participating in Project Meetings and serves as a Project Manager as needed

 Provide weekly project status reports and milestone target schedules.

 Secure approvals, follow change management process and track functional changes needed for audit review.

 Effectively interface with system business owners of GxP systems and provide technical support

 IT GxP SME who partners with QA on managing GxP enterprise applications throughout all phases of the system development lifecycle, including concept, design, implementation/validation, and operation

 Effectively interface with vendor support and maintenance & operation of the GxP systems

Functional Enhancement Management

 Prepare Function Design Documents as part of necessary configuration or development changes/needs

 Manage project tasks to implement enhancements and functional changes.

 Perform unit test, business process transactional test and controls tests and prepare documentation for approval.

 Assist programmers and developers through designing, programming, testing, deploying, maintaining, and supporting User initiatives

 Maintain system of internal controls, perform periodic testing and document procedures and results in accordance Quality requirements

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

At least 8 years of hands-on technical IT experience

 Minimum additional 5 years of experience supporting GxP (GMP, GLP, GCP) computerized systems in the biopharmaceutical/pharmaceutical industries.

 Associate's degree in a related field or relevant experience

 Full understanding of CFR Part-11 rules and their application to regulated and validated (GxP) systems

 Full understanding of Computer System validation methodology.

 Experience in requirements definition and analysis and flow charting.

 Familiarity with System Development Lifecycle and GAMP5 methodology

 Excellent communication and interpersonal skills. Must be comfortable supporting employees at all levels of the organization.

 Ability to work independently and efficiently with minimal supervision.

 Proactive team player who gets along easily with others and enjoys collaborating. o Experience with standard industry platforms/systems such as MasterControl, DocuSign 21 CFR Part 11, Veeva, TrackWise, ServiceNow etc. null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.