State recognized vocational qualification

• State recognized vocational qualification, e.g. completed specific vocational qualification, Master Craftsman qualification or course of study in the corresponding field, and
• Subsequent task relevant 5 years of professional experience on processes and/or projects in the pharma industry (proven by completing the CV model of TRR), and
• Successful participation in the „Process Engineer Expert Level in Pharma Industry “ module which has been recognized by the Personnel Certification Body PersCert TÜV. Admission to the exam is granted upon a minimum of 80% attendance of the 32 teaching units.

• Written exam

In the examination participants prove their knowledge in the following areas:

• Process interface with product development
• Process design
• Process implementation
• Continuous improvement

Successful candidates have the competence in order to:

• Use of concepts and methods related to the medicine development process, including quality principles starting with the design stage ("Quality by Design")
• Design and Use Processes, Flows, Principles and Tools Based on Good Manufacturing Practices (GMP) and Distribution (GDP)
• In-depth application of Good Practice rules in process design and optimization, equipment qualification and process validation, statistical control and regulation of processes
• Using quality risk management methods, techniques and tools
• Applying methods, procedures for non-compliance management, complaints and recalls, corrective and preventive actions to improve the quality of processes and products.

In a recertification process participants have to prove their expertise is up to date:

• Successful completion of the updated Process Engineer - Expert Level in Pharma Industry course,
  or
• Successful completion of 2-days workshop, the follow-up module of the Process-Expert Level Engineer in Pharma Industry course.