Area Quality Owner

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https : / / www.jnj.com / .

Cilag AG in Schaffhausen, Switzerland, is part of the Johnson & Johnson Innovative Medicine (J&J IM) organization, and is currently recruiting for an

Area Quality Owner (AQO) Parenterals

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 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.

The focus for our future colleague will be on processes, equipment and projects in the Parenteral departments. Experience with Compounding processes, Filling processes (isolator technology), Aseptic Process Simulations (APS), Equipment Process Validation (EPV), Smoke studies, Utility processes and Environmental monitoring is key in this role!

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
• Qualification of aseptic operators
• Actively contribute to new concepts and projects as well as suggestions for improvement in assigned departments
• Proactive risk mitigation
• Assess and approve Non-Conformances, CAPA investigations, and Corrections / CAPAs related to utilities, facility, environment and equipment. Quality investigation lead for major Non-Conformances (CAPA investigations)
• 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, MSAT, Engineering, etc.) in terms of GMP Compliance
• Participate as Subject Matter Expert in Health Authority inspections and audits