Regulated (GxP) Systems Consultant/ Validation System Consultant

Zifo is hiring.. Seeking a highly experienced senior IT professional who can seamlessly hit the ground running in supporting GxP Systems and collaborate cross-functionally with teams such as Quality, Clinical Operations, Pharmacovigilance, and more.

This role entails serving as a GxP IS representative and SME for system implementation and ongoing operations, encompassing access management, access reviews, system administration, risk management, and incident investigations.

You will work alongside the existing Regulated (GxP) Systems staff and Quality as your cross functional partner while providing support and expertise in GxP operations and projects within the realm of information systems.

Requirements

• GxP Computer System administration, support escalation point, and maintenance.
• GxP Computerized System Incident Management and technical investigation.
• Creating SOPs, Guidance Documents, and Work Instructions.
• IS 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.
• Information Systems SME and a representative that serves as a Project Manager.
• Supporting account management, routine user access reviews, and release management for GxP 30+ regulated systems.
• Effectively interface with system business owners of GxP systems and provide technical support.
• Effectively interface with vendor support and maintenance & operation of the GxP systems.
• Staying current with US and international regulations, industry standards, and emerging topics pertaining to GxP CSV, SDLC, GAMP5, GCP and GMP.
• Preparing, reviewing, and approving GxP Computerized Systems Validation lifecycle documents as an IT SME.
• Assisting in the creation and capitalization of validation tasks necessary for the project scope and objective.
• Actively participating in Project Meetings and Walkthroughs.

What minimum qualifications do we require?

• Minimum 5 years of hands-on technical IT experience.
• Minimum additional 3 years of experience supporting GxP (GMP, GLP, GCP) computerized systems.
• 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.
• Familiarity with System Development Lifecycle and GAMP5 methodology.

What additional qualifications will make you a stronger candidate?

• Experience in the life sciences industry and working knowledge of FDA and EU regulated environments.
• Experience with on-premises, hosted, and cloud/Software-as-a-Service (SaaS) delivery models.
• Proficient in communicating organizational policies and procedures.
• Experience in Change Control, incident response, and release management.
• Previous experience in validating both cloud-based and on-premise GxP solutions for their intended use.
• Ideally familiar with GAMP5, Annex 11, or 21CFR Part 11.
• Working knowledge of IT security best practices.
• Strong ability to work in a cross-functional team environment with excellent interpersonal and communication skills.
• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, and Optimism.