Emergent BioSolutions is dedicated to one simple mission to protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well.
With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.
At Emergent BioSolutions Berna, the Swiss affiliate there are - beside manufacturing activities professionals in Quality Assurance and Control, Supply Chain and Regulatory affairs working.
We are heading to the next period of growth with approx. 120 dedicated and committed professionals working on the Swiss site of Emergent in Bern / Thörishaus.
With working place in Thörishaus (Berne) we want to strengthen our Quality Assurance team with a
Associate Director QA Sterile Operations (100%)
Main responsibilities :
Technical QA lead and subject matter expert for the sterility assurance and sterile operations at the site supporting both development and commercial products
Assure the cGXP conformance of the site operations concerning aseptic processing
Represent the Bern site as SME for sterile operations with Global Emergent
Perform regular checks in the production operation for compliance with sterility assurance procedures
Supervise and ensure compliance to regulations for aseptic processing related to media fills, cleanroom design, process qualification, cleanroom cleaning, aseptic preparation activities, cleanroom behaviors and environmental excursions
Design, implement and oversee an environmental monitoring program
Evaluation of environmental monitoring data and providing recommendations.
Lead as a subject matter expert in investigations and root cause analysis concerning aseptic processing
Conduct trainings and qualifications of operators and QA in aseptic processing and clean room behavior
Collaborate with other Emergent sites on best practices
Maintain knowledge on current industry practices an d hot topics for aseptic manufacturing
Responsible for the comprehensive strategy to maintain and improve clean room controls within the facility to minimize the risk of contamination
Subject Matter Expert to the site for aseptic processing requirements for FDA and EU, as well as Swiss Medic
Qualification requirements :
University Degree in Science, Microbiology or similar
At least 7-10 years’ experience in biopharmaceuticals or pharmaceuticals with at least 5 years in aseptic processing
Strong working knowledge of Microbiology and aseptic practices
International Inspection and Audit Experience
Fluent in German and English
Strong analytical and problem-solving skills
Self-motivated and ability to work unsupervised
Good project management skills
Ability to educate and train personnel of all levels in the requirements associated with aseptic processing