Junior Area Quality Owner (Parenterals) 80-100%

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

At Johnson & Johnson, health is at the heart of everything we do. Leveraging our strength in healthcare innovation, we empower a world where diseases are prevented, treated, and even cured. At Cilag AG, part of Johnson & Johnson’s Innovative Medicine division, we produce pharmaceutical products, medical devices, and active pharmaceutical ingredients (APIs) for global markets.

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

Junior Area Quality Owner (Jr AQO) Parenterals, 80-100%

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 a Junior AQO in QA Process Parenterals, you will join a dynamic team responsible for providing guidance on Quality and Compliance, as well as overseeing the quality and aseptic conditions of equipment and premises used for manufacturing in the Business Unit Parenterals (including compounding and subsequent filling of syringes and vials), Optical Inspection, Device Assembly Packaging, and Warehouse departments at the J&J IM Schaffhausen site.

The focus for our future colleague will be on processes, equipment and projects in the Parenteral departments. Basic experience with compounding processes, filling processes (isolator technology), Aseptic Process Simulations (APS), Equipment Process Validation (EPV), smoke studies, utility processes and environmental monitoring is an advantage 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 functions
• Perform Quality and Aseptic oversight on the shop floor
• Qualification of aseptic operators

• Proactive Risk Mitigation

• Assess and approve Non-Conformances, CAPA investigations, and Corrections
• Review and approve SOPs/WIs, Change requests (COCs) and other relevant documents
• Review and approve GMP-critical SAP master data (e.g. manufacturing instructions)
• Support ‘customers’ (Operations, Quality Control, Logistics, MSAT, Engineering, etc.) in terms of GMP Compliance

Who Are You

• You hold a Bachelor’s or similar Degree in a microbiological, technical or scientific field
• You have proven experience (minimum 2 years) in a GMP-regulated aseptic pharma production environment or relevant quality role (minimum 2 years)
• Knowledge of aseptic processing is an advantage in this role
• You are fluent in German and experienced in 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 across different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will make decisions independently and provide advice as needed.