Published: 24 April 2024
Basel-Stadt
100%
Permanent position
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
Softskills
We offer you
For questions please contact Ivana Batt