Qualification Manager

Qualification Manager

Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories.

At SKAN, healthy growth is important to us. We are always looking for talented individuals to fill a wide range of roles. Apply now!

Overview

We are looking to strengthen our young Qualification Management team with an affinity for technology, documents, an eye for detail and high quality standards. We operate in the pharmaceutical environment and are therefore required to comply with strict regulations. The team creates test protocols, actively monitors their execution on our highly complex isolator systems and evaluates the resulting reports for technical approval. The scope ranges from internal conformity testing to customer qualification (IQ/OQ). Working with specifications, assessment matrices and instructions is just as much a part of everyday life as interdisciplinary and international cooperation. Continuous internal dialogue and the joy of customer-oriented project work are very important to us in order to always be one step ahead together.

Responsibilities

Responsible for the planning and implementation of qualification measures in accordance with the applicable regulations (GMP, MRL) for customer projects, maintenance and annual requalifications

Coordinating the qualification strategy with customers

Preparation of project-specific test protocols (such as IQ and OQ)

Technical assessment of test reports

Analysing and evaluating process and system data for quality control purposes

Carrying out specialised training courses, such as GMP-compliant documentation

Interface to various departments

Hardskills

• University or university of applied sciences degree in natural sciences or engineering
• Experience in a GMP environment (ideally in qualification) or in quality management
• Solid knowledge of MS Office
• Business fluent in German and English

Softskills

• Solution-orientated thinking
• High quality standards
• Responsible, careful and well-documented way of working
• Open communication and enjoyment of teamwork
• Competent and professional demeanour towards customers
• Coordination and organisational skills
• Willingness to travel (up to approx. 10%)

We offer you

• An open and collegial corporate culture
• A varied and challenging area of responsibility with a lot of autonomy
• An open communication policy
• Support through further training
• Intensive and job-oriented training, especially at our SKAN Academy
• A dynamic and international working environment
• Participation in sports and leisure activities
• 5 weeks of vacation with the option of up to 4 additional vacation weeks

For questions please contact Ivana Batt