Description
This position is for a mid size company in San Diego. They are currently growing in the right direction after recently being aquired by a large pharmaceutical company. This company has addresed the new needs that are required for the company to excel, one of them being a manager of QA IT Validation position.QA Manager, Validation
Category: Quality
Type: Employee
Description: The successful candidate will assure software validation compliance with applicable regulatory requirements including documentation generation, review and approval, training and vendor auditing. Primary Duties and Responsibilities
- 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 including EDMS and laboratory 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.
To find out more about Real please visit www.realstaffing.com