Area Quality Owner

vor 19 Stunden

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

The 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 (1 year)**

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

As an AQO in QA Process Parenterals you will join a dynamic team which is responsible for Quality and Compliance guidance, as well as Quality and Aseptic oversight of equipment and premises used for manufacturing in the Business Units Parenterals (compounding and subsequently filling of syringes and vials), Optical Inspection & Device Assembly Packaging and Warehouse departments at the JSC Schaffhausen site. As one of the current team members will go on maternity leave in a predictive future, we are looking for a colleague who quickly can support the team with a focus on processes, equipment and projects in the Parenteral departments for the duration of one year.

**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, Quality Control, 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 3 yrs) in a GMP regulated aseptic Pharma production environment, or experience in a relevant Quality role (minimum 2 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

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**
2206076144W

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