2x Junior Area Quality Owner

Vor 2 Tagen

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

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 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. Basic experience with Compounding processes, Filling processes (isolator technology), Aseptic Process Simulations (APS), Equipment Process Validation (EPV), Smoke studies, Utility processes, or 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

Qualifications
  • 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
  • Proactive Risk Mitigation
  • Assess and approve Non-Conformances, CAPA investigations, and Corrections/CAPAs related to utilities, facility, environment, and equipment.
  • Review and approve SOPs/WIs, Change requests (COCs), and other applicable 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 have a Bachelor’s or similar Degree in a microbiological, technical, or science field
  • You have proven experience (minimum 2 yrs) in a GMP regulated aseptic Pharma production environment, or experience in a relevant Quality role (minimum 2 yrs)
  • Knowledge in aseptic processing is of advantage in this role
  • You are fluent in German

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.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued and our people can reach their potential.

At Johnson & Johnson, We All Belong #J-18808-Ljbffr

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