Local Quality Owner

Vor 2 Tagen

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

**"Caring for the worldone person at a time”**inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable **Credo**

Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization within Johnson & Johnson and is currently recruiting for a

**Local Quality Owner API (M/F)**

We manufacture high quality pharmaceutical products, active pharmaceutical ingredients (APIs) and medical devices. 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.

We are currently recruiting for a Local Quality Owner in the QA Active Pharmaceutical Ingredients (API) team.

***:
The function holder is responsible for QA oversight for selected, chemically manufactured products at the JSC Schaffhausen site. This includes quality oversight for all relevant activities associated with API manufacturing, analytical testing and distribution. This includes the introduction of new chemical entities into the site.

***

**Main responsibilities**
- On-time release of clinical and commercial APIs and/or precursors for medical device
- Investigation lead for major non-conformances
- Review and approval of other non-conformances
- Investigate and manage Customer Complaints
- Review and approval of change control requests
- Review and approval of documents related to the lifecycle management of API (development reports, Criticality Analysis documents, validation documents, Continuous Process Verification documents, Master Batch Records, Product Quality Reviews)
- Maintain quality contact with external customers for which Cilag acts as contract manufacturer
- Review and approval of GMP critical SAP master data (e. g. shelf-life, date of manufacture, Detailed Material Description)
- Review and approval of work instructions and standard operating procedures
- Support and lead customer audits
- Support health authorities’ inspections (Swissmedic, US FDA)
- Issue, review and update of Quality Agreements
- Participation as QA representative in different projects
- Support of internal customers (production, logistics, engineering, etc.) in terms of GMP Compliance and Quality
- Proactive risk mitigation
- Review of batch and cleaning records
- Review of batch documentation as part of the release process

**Qualifications** Qualification**
- Master Degree in a technical or science discipline
- Minimum one (1) year of experience in a relevant quality role or two (2) years of experience in a GMP regulated API or Pharma production environment
- Strong background in regulatory guidelines preferred
- Knowledge in chemical manufacturing preferred
- Experience as team or project lead preferred
- Knowledge of SAP preferred
- Advanced communication skills in German and English (oral and written)

You are a team-oriented, dynamic and highly motivated person with strong communication skills. 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.

**This is what awaits YOU at J&J**:
An opportunity to be part of a global market leader

A dynamic and inspiring working environment

Many opportunities to work on challenging projects and assignments

Possibilities for further personal as well as professional development

Many employees benefits

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 in Switzerland 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.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong” 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, g

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