Consultant eCompliance within Quality assurance ref: 13447

Beschreibung

Welcome to Wega Informatik AG

With over two decades of experience, Wega Informatik AG has established a solid presence in IT service provision and consultancy. We have an extensive portfolio of successfully managed projects, yielding the highest customer satisfaction.

We pride ourselves in having a solid track record of long-term relationships and collaboration with our clients, winning their trust and full confidence and reaffirming our position on the market as an added value strategic partner. We are seeking a technical analyst for a large server area for middleware management


We are seeking on a contractual basis a:

Consultant eCompliance within Quality assurance ref: 13447

Role 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 Quality Manual.

Major accountabilities:
• 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
o Ensure that Data Integrity is maintained throughout the business process.
o Ensure that programming and validation procedures comply with 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.

Ideal Background:
Education: Graduate in Pharmacy, natural sciences or information technology or several years of equivalent experience in pharmaceutical or related industry

Languages: Local language, English fluent in speaking / writing


Experience: • Experience in GxP regulated Pharmaceutical Industry (e.g. 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 (e.g. 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