Computer System Validation Specialist - GMP / 21CFR11 Expert

Agupdate

Wilmington, Northern (NC, KY)

Hybrid

USD 85,000 - 110,000

Full time

9 days ago

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Benefits offered by this job

Subsidized childcare

Benefits package

Job summary

Quality Chemical Laboratories (QCL) in Wilmington, NC seeks a Computer System Validation Specialist to lead and execute validation activities in a GxP environment. Responsibilities include authoring validation plans, IQ/OQ/PQ, RTM, data integrity assessments and deviation management, with collaboration across functions.

Qualified candidates have at least 2 years in CSV, experience drafting test scripts, and knowledge of 21 CFR Part 11 and GAMP practices.

Qualifications

Two years' experience in Computer System Validation within a GxP environment.
Experience writing computer system test scripts, validation protocols and summary reports.
Knowledge of Regulatory Requirements, 21 CFR11, Data Integrity and GAMP practices.
Strong analytical and problem-solving skills; ability to manage multiple sub-projects.

Responsibilities

Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle.
Documentation includes CSV Plan, IQ, OQ, PQ, Test Scripts, Summary reports, RTM, Periodic Review and Data Integrity Assessment.
Track and resolve deviations/exceptions during qualification activities.
Work with management to implement changes and upgrades; review vendor protocols and design specs; communicate approaches during audits.
Review validated systems to assess need for further enhancements, validation, or upgrades/fixes.