Gxp Systems Consultant

Location: On-Site - Cambridge, MA.
Employment type: Contract

Zifo is 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.

 As a valued member of the Zifo team and liaison to our pharmaceutical client(s) 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

Responsibilities:

• 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

Qualifications:

• Minimum 5 years of hands-on technical IT experience
• Minimum additional 3 years of experience supporting GxP (GMP, GLP, GCP) computerized systems
• Bachelor'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

A successful Zifo-ite is:

• Independent, Self-Motivated & Results driven
• Willing & able to quickly acquire new Technical Skills & Business Principles
• A critical thinker who possesses logical reasoning
• Curious and always looking for creative solutions to complex problems

Benefits

About Zifo:

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 7 of the Top 10 Biopharma companies.

We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.