Description
Reference #: 915353NCIndustry: Pharmaceuticals
Location: Basel und Region
Start: ASAP
Duration: 30.06.2016
Workload: 100%
Introduction: Since its founding in 1997 ITech Consult AG has expanded its network of freelance IT continuously. Today we have access to over 30'000 reported IT specialists (developers, system specialists, project managers, supporters, etc.). So we are able to present computer science professionals with the required profiles in a short term.
Role:To support QA eCompliance with project deliverables as well as typical day to day operational tasks related to data integrity and the related regulatory requirements.
MAJOR ACCOUNTABILITIES:
-To provide QA eCompliance oversight as we migrate data and computer systems to other companies that have purchased them along with their associated Business Processes. In addition to this, the transitional situation requires temporary QA oversight as continue to operate the systems as well.
-To provide QA support for GxP impact computer system implementation projects. This means ensuring that projects, systems, and processes, meet the requirements of the Quality Manual.
-To provide excellent QA Operational support to IT departments. This includes assistance with GxP decision making, change control review and approval, SOP review and approval, and review/approval of other GxP related deliverables as needed.
-Toassist with the development and implementation of typical CSV related SOPs and WIs.
-To help drive Quality into IT business processes wherever possible.
-To assist with the review and comment of existing IT CSV-related templates
-To assist with any other typical QA eCompliance responsibilities as required.
Experience Required:
-At least 10 years in a GxP environment with a thorough understanding of:
-Computer Validation
-Validation of cloud solutions a plus
-21CFR, Part 11
-EU Annex 11
-Typical IT processes
-Current trends in industry related to data integrity
-GAMP5 and its full lifecycle
-Project management and SAP
-At least 7 successful years working in a QA role in a GxP environment
Education:
-B.S. in Computer Science, Engineering, or other similar scientific degree area