CSV Specialist - Katalyst Healthcares & Life Sciences

Responsibilities:

• Partner with lab scientists and technicians, engineers, IT, QAU and vendors in managing and/overseeing the completion of qualification and validation activities associated with installation, maintenance, and upgrades of equipment or systems to ensure they are completed in a compliant and timely manner.

• Create, execute and/or review GLP Laboratory equipment/software, IT systems and associated infrastructure qualification and validation related documentation.

• Assess, author and or approve IT change control, incidents, deviations and investigations related to computer systems using a risk-based approach.

• Develop, revise and maintain computer validation related SOPs.

• Train lab scientists, technicians, IT personnel and Quality Assurance Unit (QAU) personnel, as needed, on qualification/validation requirements and procedures.

• Participate in life cycle management of equipment and software through periodic reviews, change management and retirement after initial validation.

• Conduct work according to Good Laboratory Practices. (GLP)

• Maintain up-to-date knowledge of GLP/GMP and Computer Systems Validation (CSV) requirements through training and participation in external forums.

• Represent the company internally and externally in CSV.

• Analyze data to ascertain if it meets related protocol acceptance criteria.

• Write deviation reports as required upon failure to meet protocol acceptance criteria.

• Assist with the development and communication of project timeline and status.

Requirements:

• Experience coordinating and conducting qualifications and validations on IT systems and scientific equipment with associated software promptly.

• Experience working in regulated R&D environment.

• Knowledge of Good Lab Practices (GLP) or other GxP practices with a focus on Data Integrity.

• Knowledge of industry validation standards, guidelines and regulations such as GAMP 5, OECD, EPA and FDA, 21 CFR Part 11.

• Knowledge of software risk management process and analysis.

• Ability to support a large technical customer base with effective facilitation skills.

• Excellent understanding of software development life cycle process.

• Strong verbal and written communication skills.

• Project management Experience.