Principal Consultant for IT validation in pharmaceutical GMP environment at gempex. Engaging in CSV compliance consulting and training within a collaborative team.
Responsibilities
CSV compliance consulting (including ERP, databases, and automation systems such as MES, PLS and PLC)
Preparation for and support during regulatory inspections
Consulting and development of IT validation concepts in accordance with GAMP 5
Conducting training, mentoring, and contributing to the development of internal tools
Active involvement in professional associations, including presentations and expert articles
Business development and client relationship management within consulting projects
Requirements
University degree in Computer Science, Technical Computer Science, or Business Informatics with a strong affinity for computer systems
At least 10 years of professional experience in IT/CSV consulting
Excellent German and English language skills
Strong consulting skills and subject-matter expertise
Willingness to travel
Benefits
High level of personal responsibility and independent work across a variety of consulting projects
Flexible working hours and location model
30 days of vacation
Permanent employment contract
Open corporate culture with flat hierarchies and short decision-making processes
Attractive social benefits
Company car and additional benefits
Work in a team of experienced and specialized consulting experts
Opportunities to contribute to and shape the expansion of business areas
Job title
Principal Consultant – IT Validation, Pharmaceutical GMP Environment
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