Computer Systems Validation Support

Overview

Our client in the Chicago area is performing validation and qualification activities for a variety of GMP analytical instruments in a pharmaceutical GMP setting.

Who We Are

Since 2003, our life science compliance consultants have helped pharmaceutical and medical device manufacturers bring lifesaving products to market. We provide engineering validation services and FDA regulatory affairs services to life science companies across the United States. We are seeking a creative, collaborative, and strategic thinker to help expand our engineering and validation services to our current clients and new customers. We value personal accountability, corporate transparency, and professional development – we believe a positive customer experience is as important as a positive employee experience.  We thrive on hard work and fun!

What We Offer

We are proud to offer competitive benefits, salary, and an environment focused on personal and professional development.

What You’ll Do

The ideal individual will have proficiency independently performing the following activities:

• Develop User Requirements specifications, following a global SOP, and using similar documentation from legacy documents for similar instrumentation systems.
• Have a working understanding of 21 CFR Part 11 to perform Electronic Record, Electronic Signature assessments for various types of analytical instrumentation.
• Develop data integrity test scripts to challenge the functionality of the Part 11 functionality for a variety of laboratory instrument.
• As necessary to develop qualification deliverables, meet with system SMEs and validation management to ensure stakeholder alignment (Owner, Metrology, Users, Validation, QA).
• Develop quality system SOPs that address usage, maintenance, and system administration of laboratory instrumentation, such that any identified data integrity concerns are effectively managed via well-controlled procedure.
• Develop a GMP Risk Assessment table that identifies any residual risks relating to use, maintenance, calibration, administration or data integrity after the completion of necessary qualification activities, following guidelines and existing templates.
• Develop IQ/OQ protocols for various laboratory instrumentation, following global SOPs and similar documentation from legacy instruments. Such protocols shall leverage existing vendor commissioning documentation to minimize the amount of hands-on testing, and to accentuate testing customized/configured functionality, as necessary to establish adequate levels of data integrity and specific laboratory analyst needs.
• As necessary during the qualification effort, author, investigate, and close out any deviations that may arise during qualification execution.
• Address comments from QA reviewers System Owners, and other project stakeholders to ensure swift document review and approval for all developed qualification documentation.
• Under the guidance of an instrument SME, execute IQ/OQ protocols developed.
• Generate validation reports and corresponding traceability matrices for qualification efforts, thus ensuring that all qualification requirements will have been tested, meeting acceptance criteria
• Provide top-notch service to Compliance Team’s pharmaceutical client, ensuring total customer satisfaction with the compliance team’s qualification/validation service offering