Review complex GMP validation protocols and data; Review of Automation records such as FRS and SDDS. Track QA documents; Update data and run searches and reports in databases.
• Review equipment validation protocols, supporting data/documents and final reports
• Review of automation validation protocols, supporting data/documents and final reports
• Review of utility system validation protocols, supporting data/documents and final reports
• Review of Automation documents such as FRS and SDDS with ability to understand and identify changes made, possible impact, and compliance with protocols or deviation/CAPAs.
• Review of protocol deviations and CAPAs
• Attend cross functional meetings as OQ representative
• Performs other functions as necessary or as assigned.
Bachelor of Science
Science, Engineering or other technical discipline
BS with 4-5 years in a GMP environment
Including either direct validation, or quality oversight of validation and automation.
Knowledge of Biopharmaceutical manufacturing processes and equipment.
Knowledge of automation and control systems (Preferably Delta V)
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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