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QA Operations Head
Vor 7 Tagen
Why join ? DS Bioproduction Basel is an API Launch Site at the interface between Development and Commercial, producing clinical and commercial biological Drug Substance, cell banks and is the Center of Excellence for Bioassay Testing.
The QA Operations Head position involves leading a mid-sized team of QA managers, supporting the site production and QC including the CoE for bioassay testing.
Also as part of this role you will act as the deputy of the Site Quality Head and as deputy of the FvP (QP) acc.
to Swiss law.What you will do:
- Oversee Quality Operations across site.
- Inbound & Outbound QA Oversight.
- MBR review and approval.
- QA for Quality Control and AS and T.
- Initiate and drive local hiring process.
- Line responsibility and daily walkthrough.
- Lead OpEx Projects.
- Investigation of Deviation, OOx,
- Support transfer Projects & validation studies.
- Track team metrics and ensure KQI /KPI meet requirements.
- HSE incidents reporting and action follow up.
Commitment to Diversity & Inclusion:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Minimum requirements
What you will bring?
- Supporting Quality activities / issues
- Advanced University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- 35years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent
- Expertise in GxP operations
- Experience supporting audits & HA inspections
- Fluency in German
743 million the total no of patients we reached last year through our collective efforts to reimagine medicine and make a real difference to the lives of patients around the world.
how can we improve and extend even more lives in a world of digital and technological change? We are convinced that we can find answers if curious, courageous and team-oriented people are encouraged to question the status quo, make courageous decisions and follow innovative paths.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Division
Operations
Business Unit
QUALITY
Country
Switzerland
Work Location
Basel
Company/Legal Entity
Novartis Pharma AG
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
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