Compunnel
CSV Analyst / QA System Validation Supervisor
Compunnel, Alpharetta, Georgia, United States, 30239
Job Summary
We are seeking a QA System Validation Supervisor with over 8 years of experience in computer system validation (CSV) within healthcare or regulated environments.
The ideal candidate will be well-versed in regulatory standards such as 21 CFR Part 11, Annex 11, and GAMP 5, and will lead validation efforts across systems and processes to ensure compliance, data integrity, and audit readiness.
Key Responsibilities Update validation procedures including change control, training, and audit processes to maintain system validation. Write and review validation documentation such as validation plans, URS, FRS, risk assessments, traceability matrices, IQ/OQ/PQ/OPQ protocols, and reports. Support system validation project activities including protocol writing, test script review, and validation reporting. Review and approve change control requests and assess their impact on system validation status. Review and approve procedures, forms, and manuals related to validated systems. Perform audit trail reviews and document findings. Evaluate system validation status and generate corresponding reports. Assist in supplier qualification assessments and data gathering. Investigate and resolve deviations, nonconformances, CAPAs, and audit findings. Maintain document management systems to ensure availability of required documentation for audits and inspections. Support internal and external audits and validation project status reporting. Provide guidance to IT and Engineering teams to maintain validation of warehouse and support systems used in healthcare applications. Identify systems requiring validation and assess their compliance needs. Collaborate with internal teams to resolve healthcare compliance issues. Required Qualifications
Bachelor’s degree in Information Technology, Information Security, or a related field. Alternatively, eight years of relevant work experience may be substituted in lieu of formal education. 8+ years of experience in QA system validation. Strong knowledge of 21 CFR Part 11, Annex 11, and GAMP 5. Proficiency in Microsoft Office applications (Word, Excel, PowerPoint). Experience supporting large IT environments and system deployments. Expertise in Linux, Windows, and network security protocols. Preferred Qualifications
Experience with SIEM analysis and reporting. Familiarity with security frameworks such as NIST, CSF, CJIS, IRS 1075, CMS MARS-E. Knowledge of application security (AppSec).
Education:
Bachelors Degree
We are seeking a QA System Validation Supervisor with over 8 years of experience in computer system validation (CSV) within healthcare or regulated environments.
The ideal candidate will be well-versed in regulatory standards such as 21 CFR Part 11, Annex 11, and GAMP 5, and will lead validation efforts across systems and processes to ensure compliance, data integrity, and audit readiness.
Key Responsibilities Update validation procedures including change control, training, and audit processes to maintain system validation. Write and review validation documentation such as validation plans, URS, FRS, risk assessments, traceability matrices, IQ/OQ/PQ/OPQ protocols, and reports. Support system validation project activities including protocol writing, test script review, and validation reporting. Review and approve change control requests and assess their impact on system validation status. Review and approve procedures, forms, and manuals related to validated systems. Perform audit trail reviews and document findings. Evaluate system validation status and generate corresponding reports. Assist in supplier qualification assessments and data gathering. Investigate and resolve deviations, nonconformances, CAPAs, and audit findings. Maintain document management systems to ensure availability of required documentation for audits and inspections. Support internal and external audits and validation project status reporting. Provide guidance to IT and Engineering teams to maintain validation of warehouse and support systems used in healthcare applications. Identify systems requiring validation and assess their compliance needs. Collaborate with internal teams to resolve healthcare compliance issues. Required Qualifications
Bachelor’s degree in Information Technology, Information Security, or a related field. Alternatively, eight years of relevant work experience may be substituted in lieu of formal education. 8+ years of experience in QA system validation. Strong knowledge of 21 CFR Part 11, Annex 11, and GAMP 5. Proficiency in Microsoft Office applications (Word, Excel, PowerPoint). Experience supporting large IT environments and system deployments. Expertise in Linux, Windows, and network security protocols. Preferred Qualifications
Experience with SIEM analysis and reporting. Familiarity with security frameworks such as NIST, CSF, CJIS, IRS 1075, CMS MARS-E. Knowledge of application security (AppSec).
Education:
Bachelors Degree