Computer System Validation Consultant (CSQA)

CSQA - Computer System Validation Consultant - 6 Months of Contract role

Responsibilities:

Deliver on CS processes:

• Establish and maintain CSQ support and sustainability processes.

Deliver Projects and Programs

• Understand customer, company, and Quality priorities, and support 

implementation goals.

• Provide linkages to partner organizations with CSV including Automation, Site 

Equipment Verification, Business QA, and other CSQA persons.

Grow Capabilities and Knowledge

• Mentor others in CSQA / CSV-related roles

Maintain Inspection Readiness 

• Provide consulting and interpretation on Corporate Computer Systems/Data 

Integrity standards and practices as implemented at the LP1 facility.

• Provide cross-functional technical leadership in the event of serious quality-related 

issues with computer systems.

• Monitor current state of inspection-readiness.

• Escalate issues appropriately.

Streamline and Continuously Improve

• Promote common process and best practice across functions.

• Identify systemic issues and trends across functions and drive improvement 

activity.

Basic Requirements:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a 

technology-related field OR 10 years of relevant experience

• 1 years of experience in Automation/QC Labs/IT, Quality, or computer system 

validation in the pharmaceutical industry

Additional Preferences:

• Direct experience with Computer Systems Validation (GAMP5) and data integrity 

basic principles (ALCOA ). 

• Previous experience in GMP production environments

• Demonstrated strong oral and written communication skills.

• Strong interpersonal interaction skills

• Proven ability to influence quality peers, IT SMEs, and upper management.

• • Previous experience in Business Quality Assurance and Automation