CSV Analyst QA System Validation Supervisor

Alpharetta, GA - USA

Monthly Salary: Not Disclosed

Posted on: 23 days ago

Vacancies: 1 Vacancy

Job Summary

Role: CSV Analyst / QA System Validation Supervisor

Location: Alpharetta GA (Onsite)

Type: Contract

Description:

QA System Validation Supervisor with 8 Years exp
Knowledgeable in 21 CFR Part 11 Annex 11 and GAMP 5
Updates validation procedures including change control training and audits to ensure the maintenance of system validation.
Writes and reviews technical validation documents (e.g. validation plan URS FRS Risk Assessment Traceability Matrix IQ/OQ/PQ/OPQ protocol report etc.)
Assists in system validation project activities (e.g. writing protocols reviewing/approving test scripts drafting validation reports etc.)
Review and approve Change Control requests and assesses the impact on system validation status.
Review and approve procedures forms and manuals.
Perform audit trail reviews and document results.
Perform system validation status evaluations and complete reports.
Assist with supplier qualification assessment data gathering.
Investigate review approve and perform corrective actions for deviations (i.e. nonconformances and CAPAs) and audit findings.
Maintains the document management system for healthcare facilities and distribution centers to ensure required documents and data are available for regulatory agency audits and inspections
Supports internal and external audits
Supports validation project status reports to communicate project goals contingency plans and issue resolutions to project teams and clients
Tasks identified:
Provides guidance to Supply Chain Solutions (SCS) Information Technology (IT) and Engineering departments to maintain validation of warehouse and/or support systems utilized for healthcare applications.
Identify systems used in healthcare that require validation and assess and evaluate the applications for system validation requirements.
Consults with internal groups (e.g. Operations Business Development IT etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.

Mandatory Skills:

Proficient with Microsoft Office applications (Word Excel and PowerPoint)

Role: CSV Analyst / QA System Validation Supervisor Location: Alpharetta GA (Onsite) Type: Contract Description: QA System Validation Supervisor with 8 Years exp Knowledgeable in 21 CFR Part 11 Annex 11 and GAMP 5 Updates validation procedures including change control training and audits to ensure...

Role: CSV Analyst / QA System Validation Supervisor

Location: Alpharetta GA (Onsite)

Type: Contract

Description:

QA System Validation Supervisor with 8 Years exp
Knowledgeable in 21 CFR Part 11 Annex 11 and GAMP 5
Updates validation procedures including change control training and audits to ensure the maintenance of system validation.
Writes and reviews technical validation documents (e.g. validation plan URS FRS Risk Assessment Traceability Matrix IQ/OQ/PQ/OPQ protocol report etc.)
Assists in system validation project activities (e.g. writing protocols reviewing/approving test scripts drafting validation reports etc.)
Review and approve Change Control requests and assesses the impact on system validation status.
Review and approve procedures forms and manuals.
Perform audit trail reviews and document results.
Perform system validation status evaluations and complete reports.
Assist with supplier qualification assessment data gathering.
Investigate review approve and perform corrective actions for deviations (i.e. nonconformances and CAPAs) and audit findings.
Maintains the document management system for healthcare facilities and distribution centers to ensure required documents and data are available for regulatory agency audits and inspections
Supports internal and external audits
Supports validation project status reports to communicate project goals contingency plans and issue resolutions to project teams and clients
Tasks identified:
Provides guidance to Supply Chain Solutions (SCS) Information Technology (IT) and Engineering departments to maintain validation of warehouse and/or support systems utilized for healthcare applications.
Identify systems used in healthcare that require validation and assess and evaluate the applications for system validation requirements.
Consults with internal groups (e.g. Operations Business Development IT etc.) and investigates and resolves healthcare issues to ensure compliance with rules and regulations.