QA Project/Process Quality Manager

QA Project/Process Quality Manager

Edelway SA is a Swiss IT Services Consultancy. Our global multinational end-client based in Basel is currently looking to hire a QA Project/Process Quality Manager on a long-term basis.

Working language: English.

Full time Engagement at least until end of September (possible extension)

Starting Date: ASAP

THE ROLE:

*Ensure that all GxP Computerized Systems comply with the requirements of the Corporate Quality Manual and meet all relevant GxP regulatory requirements throughout the systems life cycle.
*Specifically
- Ensure that Data Integrity is maintained throughout the business process.
- Ensure that programming and validation procedures comply to the requirements of the Corporate Quality Manual.

*Review, evaluation, and approval of Computerized System related quality concepts, plans and documents of divisional and local projects and applications.
*Oversee QA operations for computerized systems validations and change control.
*Review/approve validation deliverables for global computerized systems in the QA role.

YOUR PROFILE:
*Experience in GxP regulated Pharmaceutical Industry (eg in Quality Assurance) IT departments, Quality Management Departments or equivalent Consultant positions
*Excellent knowledge of computerized system validation aspects and 21 CFR Part 11/EU Annex 11 requirements.
*Good experience with Quality Management and Computerized Systems Validation aspects of application implementations and operations (eg Clinical Data Management Systems, ERP/SAP, DMS, LIMS) in the regulated Pharmaceutical Industry.
*Knowledge in scientific and clinical data management and statistical programming is an advantage
*Experience in the pharmaceutical industry in a MUST
*Fluent English, German is an asset

If it sounds like your next challenge, send your CV and we will contact you shortly to discuss it further.

Keyword: Pharma, pharmaceutical, GxP, Validation, Quality, QA, QM, CSV, Basel, Switzerland, Schweiz