IT Quality Manager

For our client, a dynamic and multinational pharmaceutical company in Basel, Switzerland, we are looking for a motivated and ambitious:

IT QUALITY MANAGER

MAJOR ACCOUNTABILITIES

-The key project that this person will support is 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 clients 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.
- As our client continues to centralize its computer systems and services, the person in this role will assist 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.

MAIN REQUIREMENTS

- B.S. in Computer Science, Engineering, or other similar scientific degree area
- Minimum 5 years in a GxP en-vironment 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 life cycle
- Project management
-SAP

DURATION: 02.11.2015 - 30.06.2016 (Extension optional)

Are you interested to work in this challenging position? Robert Stanislawek, Senior Consultant, is looking forward to receiving your complete profile. Please send an e-mail to (see below)