QA Compliance Specialist
Infos sur l'emploi
- Date de publication :14 février 2025
- Taux d'activité :80 – 100%
- Type de contrat :Durée indéterminée
- Langue :allemand (Courant), anglais (Courant)
- Lieu de travail :Oberriedstrasse 68, 3174 Bern
For us, it is all about improving and saving lives
In Bern, we're not just expanding-we're reaching a major milestone by launching a new production site and introducing innovative ways of working. This is what being a Persistent Pioneer in our BN DNA is all about bringing a pioneering spirit to everything we do. Whether you're an experienced professional, transitioning from academia, or coming from a related industry, you'll have the unique opportunity to influence how we work and grow.
To complement and strengthen our Quality Assurance Team we are looking for a
QA Compliance Specialist 80 - 100% (f/m/d)
Boost our teamOur highly skilled and experienced QA Compliance team work closely with various departments such as MSAT, Production, Supply Chain, QA, Engineering, and QC. Working as a QA Compliance Specialist is technically engaging, offering diverse daily tasks and a comprehensive departmental overview. The team fosters continuous development and extraordinary achievements to ensure the safety of our vaccine production.
Responsible, as QA representative in multidisciplinary teams, to oversee the following topics:
- Deviation, Change Control, CAPA Management, Continuous improvements
- Process Validation
- Product Quality Review (PQR)
What you can expect
- Reviews and approves deviations, investigations, CAPAs and Change Controls
- Reviews and approves process validation documents including risk assessments
- Oversees site manufacturing activities (oral and parenteral)
- Establishes annual Product Quality Reviews
- Ensures regulatory compliance and continuously improves the allocated quality systems and procedures
- Participates in audits and inspection within the area of responsibility
What do you bring to it
- Master's degree preferrably in Life Sciences or related field
- Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry
- Solid computer skills including MS Office required / SAP, LIMS, Quality Management Systems skills are a plus
- Analytical thinking and problem-solving attitude
- Multilingual - at least German and English, written and spoken
We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile QA team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills.
Are you ready to join us in our mission?
If this sounds like the next step in your career, we would love to hear from you. Simply click the "APPLY" button on the right side of the page and you will be redirected to our application form. We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible.
We look forward to receiving your motivated CV, where you briefly explain your motivation for applying for this particular position. A cover letter is optional.
We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.
Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer.
www.bavarian-nordic.com
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