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IT Documentation Specialist

Systematix is currently looking for an IT GxP Documentation Specialist to work with our client’s QA teams to update the documentation of deliverables for IT Hosting Infrastructure GxP Qualification.

About the Project

Our client is one of the leading Global Life Sciences companies, with offices around the globe. Working as GxP IT Infrastructure Documentation Specialist, you will work with cross-functional teams; especially with QA teams to seek feedback and update the IT infrastructure GxP Documentation for Qualification process. Your background in Quality and Compliance will help to support IT infrastructure qualification and validation activities as well as documentation deliverables for regulated GxP systems.

Your responsibilities in the role will be:

• Review and Update the IT GxP Infrastructure documentation – SOPs, WIs and templates
• Work closely with QA team in the Review and Approval of the documentation in Veeva
• Operate daily activities under the guidance of GxP IT hosting infrastructure management
• Independently author qualification documents such as risk assessments, qualification plans, qualification protocols, and qualification summary reports
• Collaborate with global/functional infrastructure teams to draft, review, and approve qualification results for infrastructure used in GxP environments.
• Maintain the qualified IT hosting infrastructure systems for GxP us
• Ability to work in a team environment and independently as require
• Collaborate and coordinate with the functional IT teams to support infrastructure Qualification activities for GxP systems

About the Qualifications

• A bachelor’s degree in science, technology, or another relevant academic discipline.
• Must have a minimum of 5 years of experience in IT Quality & Compliance documentation for GxP Qualification and Validation activities
• Minimum of 3 years of experience working in GAMP 5, FDA regulated GxP IT infrastructure qualification and validation in a regulated industry with understanding of compliance standards
• Ability to create and update GxP documentation for IT infrastructure Qualification
• Excellent interpersonal and communication skills with ability to work collaboratively within a team of stakeholders and QA teams globally.
• Quality orientated with strong attention toward details.

About the Role

This is a 3-month remote contract role to be performed in the Eastern time zone.

Apply Now

If you are interested in finding out more, please contact us or submit your resume. Or, if you know someone who meets these qualifications, please forward this assignment.

About Systematix

Systematix is one of North America’s largest privately owned National Consulting and Resourcing firms. We provide the highest caliber consulting solutions to a diverse client base that includes all levels of Government and all Private Industry sectors.