Emergent BioSolutions is dedicated to one simple missionto 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, Quality Control, Supply Chain and Regulatory affairs working. On the Swiss site of Emergent in Thrishaus / Bern there is approx. 140 dedicated and committed professionals working locally and globally.
Emergent is looking to support the Quality Assurance (QA) Operations Team with a
QA Operations Manager (f/m) 100%
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Main Responsibilities:
Batch Record Review, technical release of raw materials, intermediates, and final product
Preparation of market release and certification of final product for the Swiss Market
Quality assurance of deviations, CAPA, change control and complaints
Quality assurance and authoring of controlled documents
Site representation in global QMS projects and implementation of global initiatives at the site
Management of raw material and product specifications
Product Quality Reviews and KPI reporting
Training of site employees
Active participation in inspections and audits
Our Requirements:
University degree in natural science, medicine, or pharmacy
Minimum three years experience in GMP-regulated industry, preferably in a QA/QC position
Self-confident and strong interpersonal skills, well able to manage all types of stakeholders and situations
Able to work with a high degree of autonomy and self-management, being able to proactively find solution to issues and knowing when to escalate
Excellent verbal and written communication skills in English and German
ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.
WE BELIEVE IN OUR VALUES
Stand shoulder to shoulder no matter what
We combine our best thinking and communicate openly to support each other.
Break through thinking
We take smart risks, pursue innovation and challenge ourselves to constantly improve.
Own it always
Every person at Emergent is engaged and accountable for delivering on our commitments.
Compete where it counts
We set the right goals and respect each other as we conquer them together.
