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- Challenges and Chances: A Review of the 1st Stem Cell Community Day
- Summertime, and the Livin’ Is Easy…
- Follow-on-Biologics – More than Simple Generics
- Bacteria Versus Body Cells: A 1:1 Tie
- Behind the Crime Scene: How Biological Traces Can Help to Convict Offenders
- Every 3 Seconds Someone in the World Is Affected by Alzheimer's
- HIV – It’s Still Not Under Control…
- How Many Will Be Convicted This Time?
- Malaria – the Battle is Not Lost
- Physicians on Standby: The Annual Flu Season Can Be Serious
- At the Forefront in Fighting Cancer
- Molecular Motors: Think Small and yet Smaller Again…
- Liquid Biopsy: Novel Methods May Ease Cancer Detection and Therapy
- They Are Invisible, Sneaky and Disgusting – But Today It’s Their Special Day!
- How Many Cells Are in Your Body? Probably More Than You Think!
- What You Need to Know about Antibiotic Resistance – Findings, Facts and Good Intentions
- Why Do Old Men Have Big Ears?
- The Condemned Live Longer: A Potential Paradigm Shift in Genetics
- From Research to Commerce
- Chronobiology – How the Cold Seasons Influence Our Biorhythms
- Taskforce Microbots: Targeted Treatment from Inside the Body
- Eyes on Cancer Therapy
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GMP Assurance Manager / Specialist (m/w/d)
Karrierelevel: Direct Entry
Anstellung: Fulltime, permanent
Start: Immediately
Standort: Jülich
Job-ID: R11187
Unternehmen: DASGIP Information and Process Technology GmbH
Would you like to work for a company who has made it its mission to make a contribution to improving human living conditions? With around 5,000 employees worldwide Eppendorf is a leading Life Sciences company. We develop and distribute devices, consumables and services for use in laboratories worldwide. Our daily work is characterized by our principle: Collaborate on new ideas. You would like to take responsibility and help to make a difference in an experienced international company? Exciting tasks combined with a positive and affirmative working environment await you at Eppendorf. You are also motivated by technical challenges? Then apply now!
Your challenges
Author, own and maintain internal guidance and training documentation
Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance
Review documents to ensure alignment regarding GMP customer expectations and suitability in the framework of GMP guidelines
Provide target group specific trainings and participate in global broadcast presentations
Close collaboration with the Quality team to align on concept and proper application of existing quality systems and support their development
Providing active support to colleagues in implementing requirements and translate them into solutions
Your expertise
Degree (Bachelor, Master, PhD) in the field of natural science, biotechnology or comparable
Solid quality background, specifically with core GxP systems like Change Control, Deviation Management, CAPA
Professional experience in quality or regulatory in manufacturing pharma industry, CMO/CDO/CDMO companies or in industry developing, manufacturing, and marketing of equipment for use in pharmaceutical manufacturing
Professional experience with specific quality tools used in pharmaceutical industry like: Computer software validation (CSV) based on the principles of e.g. 21CFR11, Equipment qualification (IQ/OQ) Eurdalex Vol 4 Annex 15, Process Validation, Extractable / Leachable data generation and evaluation, Critical impurities and contact material compliance (e.g. TSE)
Excellent communication skills in German and English in spoken and writing
Accurate and detail-oriented mindset
Highly skilled in standard Microsoft Office applications
Passionate and motivating attitude
Your benefits at Eppendorf
Your work is meaningful. Together we contribute to improve human living conditions.
- We offer you creative freedom with a strong, international premium brand in the life science industry.
- Thirty vacation days per year and company-regulated special leave days are a given with us.
- With our flexible flextime framework and a working time account, you can plan your working hours individually and independently create a balanced work-life balance.
- We also offer you the opportunity to work remotely across Germany for part of your working time, tailored to suit your life situation.
- We provide you with a variety of social benefits, such as additional employer-funded retirement plans, a job bike, public transport subsidies, corporate benefits, etc.
- To deepen your knowledge and continuously develop professionally and personally, we offer you a wide range of freely selectable training sessions, participation in conferences, and access to learning platforms.
- With us, you will find a diverse, open-minded, and appreciative work environment with the latest technologies, methods, and tools in a set
Bitte beachten Sie, dass wir grundsätzlich nur Bewerbungen berücksichtigen, die online über unser Bewerbermanagementsystem eingehen.
Wir freuen uns, Sie kennenzulernen!
Bei weiteren Fragen wenden Sie sich bitte an
Mechthild Lautenschläger,
lautenschlaeger.m@eppendorf.de
Eppendorf. Collaborate on new ideas.