IT Expert Laboratory (m/f) - 2 years limited

Job description

Job Description

As part of a project team for evaluation and validation of laboratory software and instrument software, the IT Expert is responsible for
• Performing qualifications of various analytical instruments and/or equipment
• Supporting project teams and system owners on qualification procedures
• Timely preparation of validation and qualification documentation (following the Novartis IT requirements)
• Preparation of data pathway maps for the development centers
• Supporting vendors during software installation and creation and maintenance of system documents on data lifecycle
• Ensuring that all software in the laboratories is compliant with MHRA, 21 CFR Part 11 and Novartis data integrity requirements
• Addressing observations raised during audits, inspections and self-inspection
• Single point of contact between Product Development, local and global IT and other business partners; Member of a global business support team for multisite global applications
• Supporting implementation of global IT initiatives in Holzkirchen and Rudolstadt

Within the operational support for laboratory systems, the IT Expert is responsible for the following:
• User Access Management
• Incident and Problem Management
• Testing of new functionalities
• Preparation of data pathway maps
• Retirement of systems
• Investigation of technical questions with laboratory equipment hardware and laboratory IT systems
Position Title

IT Expert Laboratory (m/f) - 2 years limited

Desired profile

Minimum requirements

• Successfully completed Bachelor Degree of IT, information management or an equivalent education
• Experience in IT project management, change management, IT application / system management
• Experience within the pharmaceutical industry and working in a GMP environment is very advantageous
• Knowledge of 21 CFR Part 11 and MHRA data integrity requirements is critical
• Fluent in German and English
• The role requires traveling

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
Job Type

Full Time
Country

Germany
Work Location

Holzkirchen (near Munich)
Functional Area

Research & Development
Division

SANDOZ
Business Unit

Product Dev SZ
Employment Type

Regular
Company/Legal Entity

Hexal AG