Area Quality Owner
View: 125
Update day: 21-03-2024
Location: Schaffhausen Schaffhausen SH
Category: Sales
Industry: Medical Equipment Manufacturing Hospitals Health Care Pharmaceutical Manufacturing
Job type: Full-time
Job content
The Cilag AG in Schaffhausen, Switzerland, is part of the Janssen Supply Chain (JSC) organization, within Johnson & Johnson and is currently recruiting for anArea 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.
Are you interested in joining a team that is positively impacting patients’ lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!
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, Quality Control, Logistics, Technical Operations, Engineering, etc.) in terms of GMP Compliance
- Participation as Subject Matter Expert in Health Authority inspections and audits
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
Primary Location
Switzerland-Schaffhausen-Schaffhausen-
Organization
Cilag AG (8562)
Job Function
Quality
Requisition ID
2206076144W
Deadline: 05-05-2024
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