Area Quality Owner

vor 20 Stunden

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

Cilag AG in Schaffhausen, Switzerland, is part of the Janssen Supply Chain (JSC) organization, within Johnson & Johnson and is currently recruiting for an

**Area Quality Owner (AQO), temporary position**

We manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen JSC facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products

**Position summary**

**Your responsibilities**
- Provide Quality and Compliance guidance to assigned departments and corresponding supporting departments
- Perform Quality and Aseptic oversight on the shop floor
- Actively contribute to new concepts and projects as well as suggestions for improvement in assigned departments
- Proactive risk mitigation
- Assess and approve Quality investigations (QIs) and Corrections/ CPAs related to utilities, facility, environment and equipment. Quality investigation lead for major non-conformances (deviations)
- Review and approve Protocols, Reports, SOPs/WIs, Change requests (COCs) and other applicable documents
- Review and approve GMP critical SAP master data (e. g. manufacturing instructions)
- Support ‚customers‘ (Production, Logistics, Technical Operations, Engineering, etc.) in terms of GMP Compliance
- Participation as Subject Matter Expert in Health Authority inspections and audits

**Qualifications** Who are you**
- You have a Bachelor or Master’s Degree in a microbiological, technical or science field
- You have proven experience (minimum 5 yrs) in a GMP regulated aseptic Pharma production environment, or experience in a relevant Quality role (minimum 3 yrs)
- You demonstrate strong technical and process background in parenteral fill/ finish production
- You have exceptional knowledge in aseptic processing
- You have experience as team or project lead
- You are fluent in German and English

Further, if you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence and a reasonable degree of authority. You will take decisions independently and provide advice as needed.

**Primary Location**
Switzerland-Schaffhausen-Schaffhausen
- **Organization**
Cilag AG (8562)

**Job Function**
Quality

**Requisition ID**
2206028351W

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