| Location | Glattpark-Opfikon, Switzerland |
|---|---|
| Business Sector | Biotechnology |
| Contact name | Merel van Os |
| Contact email | |
| Job ref | 24778 |
| Published | 7 days ago |
Our client is currently looking for a Quality Assurance Senior Expert to support the implementation of a new Fill & Finish and Visual Inspection area. In this role, you will also provide QA oversight for routine GMP operations within the Fill & Finish area. You’ll play a key part in ensuring quality and compliance across systems and documentation, adhering to regulatory standards and internal guidelines.
Your responsibilities will include:
Preparing, reviewing, and approving controlled documentation and revisions
Managing and reviewing deviations linked to production events, including investigation reports, impact assessments, and CAPA definition (via systems such as Trackwise)
Attending all relevant cross-functional meetings to ensure smooth collaboration and alignment
Respecting and acting in line with the internal escalation process
Ensuring completion of relevant training and software access according to company policies
Supporting with general quality oversight activities as needed (e.g. continuous improvement projects, GMP tours, batch record reviews)
Please note: this is a site-based position. Occasional home office may be allowed for specific tasks upon request.
Your profile:
Scientific/technical academic background (minimum MSc level or equivalent)
2–3 years of operational experience in a cGMP environment within a QA department on a sterile injectable pharmaceutical manufacturing site
Solid understanding of manufacturing processes (from cell culture to aseptic filling), including equipment, gowning, environmental monitoring, and lab testing
Good knowledge of quality guidelines and systems (Deviations, CAPA, Change Control, Training, Documentation)
Strong writing skills in French and/or English
Fluency in both French and English is required
Confident user of Microsoft Office tools
Strong sense of teamwork, autonomy, and agility
Practicalities:
On-site presence: Minimum 4 days per week
Home office: Occasionally possible for specific tasks upon request
Reporting line: QA Manager
Key interfaces: Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training
INTERESTED?
Interviews and offers can happen in coming 2 weeks!
If you’re interested in the above description, please apply with your CV today. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at m.vanos@panda-int.com