GMP-Expert / Calibration Specialist (m/w/d) — Roche
- Location
- Basel
- Contract
- Full-time
- Posted
- 2 days ago
Full description
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
As GMP expert (m/f/d) in the calibration team, you are the central interface when it comes to clear, comprehensible and GMP-compliant documentation. You bring complex technical processes to the point and ensure that our standards and processes are documented audit-proof at all times. You also play an important role in system maintenance within the ASPIRE program.
The possibility
In the calibration team, you can expect varied tasks
- SOPs & process flows: You create, revise and maintain standard operating procedures (SOPs), work instructions and technical documents independently.
- System Maintenance & ASPIRE Integration: You maintain and update master and process data in our calibration systems (CCMS / SAP).
- Deviations & Change Management: You write and edit deviation reports (deviations) and planned events (changes) in Veeva Vault.
- Rootcause & risk analyses: You support our team with root cause analyses (RCA) and risk analyses (e.g. FMEA).
- Interface work: You work closely and at eye level with the calibration technicians, maintenance, engineering, production, MSAT and quality.
- Projects: You bring ideas to improve the quality, efficiency of the calibration processes and cost reduction and actively drive their implementation.
Who you are
- Education: Completed studies (e.g. pharmaceutical engineering, engineering) or comparable technical/pharmaceutical training.
- Experience: First experience in technical writing (SOPs, process descriptions) – ideally in the GMP-regulated pharmaceutical environment or a comparable technical industry.
- Quality & system understanding: You understand what is important in SOPs, process flows and deviations, and bring affinity for system maintenance and data processes (e.g. CCMS, Veeva, ASPIRE / SAP).
- Language competence: Fluent German AND English (in word and writing) are a matter of course for you.
- Team spirit & personality: You are helpful, flexible, enjoy joint success and see yourself as a reliable contact person for your colleagues.
Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!
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.
Questions about this listing
What salary does Roche offer for this role?
The original listing does not state a salary. Our estimate for this role and sector in Basel is CHF 62'000 - 94'000 gross per year — an estimate, not a figure communicated by Roche. The calculator on this site converts a gross salary into your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Roche offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Roche during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Roche?
Use the "Apply now" button on this page — it links directly to Roche's original listing at roche.wd3.myworkdayjobs.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
