2013…..NOW HIRING in San Diego….QA Manager Validation…..Ardea Biosciences/Astra Zeneca
Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases. Ardea is searching for a QA Manager, Validation to join the team.
The successful candidate will assure software validation compliance with applicable regulatory requirements including documentation generation, review and approval, training and vendor auditing.
For more Information about Position Responsibilities and Requirements - Interested parties please apply today at: www.ardeabio.com/careers
No third party recruiters Please
•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.