Area Quality Owner - 2406197377W

Description

Johnson & Johnson is currently seeking an

Area Quality Owner (m/f/d)

to join our team located in Schaffhausen, Switzerland.

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/ .

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 Nonconformances, 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

Qualifications

Your profile:

• 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

• Exceptional knowledge in aseptic processing is key in this role!

• You have experience as team or project lead

• You are fluent in German and English

What we offer:

Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.

We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program and our company fitness center take care of your mental and physical well-being.

Working at Johnson & Johnson:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

We are offering you a diversified position with a variety of responsibilities in a dynamic and complex international environment. If you we have sparked your interest then please send us your complete online application (CV, cover letter) in English.

Primary Location Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen

Organization Cilag AG (8562)

Job Function Quality Assurance

Req ID: 2406197377W