Beschreibung
Adecco IT is currently looking for a Senior QA/Process Quality Manager on behalf of its client, a major global company in the Healthcare sector located in Basel.
Job Purpose:
Support QA e-Compliance Managers to ensure that all aspects of global and local Computerized Systems comply with GxP regulatory requirements and the related NV&D Quality Manual.
Major Accountabilities:
- Ensure that all GxP Computerized Systems comply with the requirements of the NV&D Corporate Quality Manual and meet all relevant GxP regulatory requirements throughout the systems life cycle.
- Ensure that Data Integrity is maintained throughout the business process.
- Ensure that programming and validation procedures comply to the requirements of the NV&D 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
Expected experience:
- Experience in GxP regulated Pharmaceutical Industry (eg in Quality Assurance), IT departments, Quality Management Departments or equivalent Consultant positions with 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.
Miscellaneous:
- Graduate in Pharmacy, natural sciences or information technology or several years of equivalent experience in pharmaceutical or related industry.
- Strong written and oral communication skills in English
- START: immediately
- Duration: 6 months
- Workload: 100% in Basel