The successful candidate will assure software validation compliance with applicable regulatory requirements including documentation generation, review and approval, training and vendor auditing.
• Manage the software validation program, including generating, reviewing and approving validation documents and performing risk and US 21 CFR Part 11 and EU Annex 11 assessments.
• Manage the software change control system; assess validation requirements of changes/updates to validated software systems.
• Represent and interface with Information Technology and other applicable system owner groups to provide validation and 21 CFR Part 11/Annex 11 guidance’s in an effective manner.
• Trouble-shoot and take the initiative on any QA-related issues for software validation compliance.
• Perform internal audits of validated systems to ensure compliance with procedures and protocols.
• Conduct vendor qualification audits for software vendors.
• Perform CRF and edit check review for data management prior to user acceptance testing.
• Perform training on software validation topics including general software validation, 21 CFR Part 11 regulations and Annex 11 guidelines.
• Develop, revise and review Standard Operating Procedures.
• Provide assistance as necessary in GMP batch record review and/or vendor qualification audits.
• Carry out job responsibilities and assignments safely and maintain a clean and safe work area.
• Other duties as may be necessary.