Qualification Engineer Consultant

Hours per week: Full-time

Start of assignment:

Duration of assignment:

INOSOLVE specializes in advising and supporting companies in the pharmaceutical, biotechnology and medical technology sectors as well as supporting pharmacies and hospitals. INOSOLVE offices are located in Vienna, Tyrol, Dubai, Cologne and Marburg.

A Qualifier (m/f/d) in the pharmaceutical industry is a person who is responsible for ensuring that manufacturing processes, equipment and facilities comply with regulatory requirements and internal quality standards. Qualifiers play an important role in the validation of production processes and equipment to ensure that the medicines produced are safe, effective and of the highest quality.

The Qualifier's (m/f/d) main tasks may include the following:

• Preparation of qualification plans:
• The Qualifier is responsible for developing plans for how qualification of manufacturing equipment and processes will be carried out. This includes defining test procedures and protocols.
• Performing qualification tests:
• The qualifier performs the tests according to the established plans. This may include the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Documentation:
• The qualifier documents all tests performed and results according to the applicable regulations and guidelines. Accurate documentation is critical to ensure compliance with quality standards and to be prepared for inspections by regulatory authorities.
• Deviation management:
• If deviations occur during qualification, the qualifier is responsible for documenting, investigating and taking corrective action to ensure equipment and processes are in compliance.
• Analysis:
• Performing risk analyses as part of plant and equipment qualification.
• Optimization:
• Developing and implementing measures for process optimization and quality assurance.
• Teamwork:
• Close cooperation with various departments such as production, quality assurance and engineering.
• Training:

The qualifier may also provide training to employees to ensure they understand the qualification requirements and can perform the processes properly.

Overall, qualifiers play a critical role in ensuring that production equipment and processes in the pharmaceutical industry meet the high-quality standards required to manufacture drugs.

Requirements:

We are looking for applicants (m/f/d) with the following qualifications and characteristics:

• Completed technical or pharmaceutical/chemical training (desirable process engineer, laboratory technician) or experience in a comparable field.
• Experience in the GMP environment.
• Sound knowledge in the implementation of risk analyses and documentation of deviations.
• Affinity for creating (technical) documentation.
• Very good written and spoken German and English.
• Confident handling of the MS Office package.
• High sense of responsibility and quality awareness.
• Accuracy is a basic requirement.

Strong teamwork, communication and organizational skills.