RocheGMP-Expert / Calibration Specialist (m/w/d)
Roche is hiring a GMP-Expert / Calibration Specialist (m/w/d) in Basel, Switzerland. Level rates it ; you can apply on Roche.
Level's read on this job
- Little AI ●○○○ is how Level rates this role: aI is not part of the work.
- Tools and skills the posting cites include SAP, Veeva Vault and gmp.
- Level classifies it as a mid-level role.
- Level lists 1,200+ other open roles at Roche.
- The role was posted within the past week.
AI in this role
GMP-Expert / Calibration Specialist responsible for calibration documentation, SOPs, and system maintenance within the ASPIRE program.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Als GMP Experte (m/w/d) im Kalibrier-Team bist du die zentrale Schnittstelle, wenn es um klare, verständliche und GMP-konforme Dokumentation geht. Du bringst komplexe technische Prozesse auf den Punkt und stellst sicher, dass unsere Standards und Abläufe jederzeit audit-sicher dokumentiert sind. Zudem spielst du eine wichtige Rolle bei der System-Pflege im Rahmen des ASPIRE-Programms.
Die Möglichkeit
Im Kalibrier-Team erwarten dich abwechlunsreiche Aufgaben:
- SOPs & Prozessabläufe: Du erstellst, überarbeitest und pflegst Standard Operating Procedures (SOPs), Arbeitsanweisungen und technische Dokumente eigenverantwortlich.
- System-Pflege & ASPIRE Integration: Du pflegst und aktualisierst Stamm- und Prozessdaten in unseren Kalibrier-Systemen (CCMS / SAP).
- Deviations & Change Management: Du verfasst und bearbeitest Abweichungsberichte (Deviations) sowie Planned Events (Changes) in Veeva Vault.
- Rootcause- & Risikoanalysen: Du unterstützt unser Team fachlich bei Ursachenanalysen (RCA) und Risikoanalysen (z. B. FMEA).
- Schnittstellenarbeit: Du arbeitest eng und auf Augenhöhe mit den Kalibrier-Technikern, der Instandhaltung, dem Engineering, der Produktion, MSAT und Quality zusammen.
- Projekte: Du bringst Ideen zur Verbesserung der Qualität, Effizienz der Kalibrierprozesse und der Kostenreduktion ein und treibst deren Umsetzung aktiv voran.
Wer Du bist
- Ausbildung: Abgeschlossenes Studium (z. B. Pharmatechnik, Ingenieurwesen) oder eine vergleichbare technische/pharmazeutische Ausbildung.
- Erfahrung: Erste Erfahrung im Technical Writing (SOPs, Prozessbeschreibungen) – idealerweise im GMP-regulierten Pharma-Umfeld oder einer vergleichbaren technischen Industrie.
- Qualitäts- & Systemverständnis: Du verstehst, worauf es bei SOPs, Prozessabläufen und Deviations ankommt, und bringst Affinität für System-Pflege und Datenprozesse (z. B. CCMS, Veeva, ASPIRE / SAP) mit.
- Sprachkompetenz: Fließendes Deutsch UND Englisch (in Wort und Schrift) sind für dich selbstverständlich.
- Teamgeist & Persönlichkeit: Du bist hilfsbereit, flexibel, bringst Freude am gemeinsamen Erfolg mit und verstehst dich als verlässliche Ansprechperson für deine Kolleginnen und Kollegen.
Bereit für den nächsten Schritt? Wir freuen uns darauf, von dir zu hören. Bewirb dich jetzt, um diese spannende Möglichkeit zu entdecken!
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
How we rate this
GMP-Expert / Calibration Specialist (m/w/d) at Roche rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where gmp was part of your work. What did you do?
- Tell me about a project where calibration was part of your work. What did you do?
- Tell me about a project where technical writing was part of your work. What did you do?
- Tell me about a project where fmea was part of your work. What did you do?
- Walk me through how you've used SAP in your day-to-day work.
Adapt your resume
- List these exact terms on your resume: Gmp, Calibration, Technical Writing, Fmea, and SAP. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
Want an expert to read your CV for this job?
Free. Send your CV and the role you want next. You get your review by email within 24 hours.
Get new AI jobs by email
One email a week with the new AI jobs, each rated for how much AI is in the work. No recruiter spam, unsubscribe in one click.
Free. One email a week. Unsubscribe in one click.
Similar roles
Other roles that involve little AI, at other companies.
What kind of AI work fits you?
Answer 12 practical questions in about three minutes. Get a simple profile, the work it points to, and live roles to explore next.
Find my next step