ID No. 0000062090: Process Engineer - Expert Level in Pharma Industry with TÜV Rheinland Certified Qualification

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Certification Program Title:Process Engineer - Expert Level in Pharma Industry with TÜV Rheinland Certified Qualification
Admission Requirements:

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.
Examination Components:
  • Written exam
Required Competencies:

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.
Recertification:

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.
Currently implemented in:Romania