Junior Local Quality Owner I

vor 1 Tag

Schaffhausen, Schweiz Johnson & Johnson Vollzeit

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

Junior Local Quality Owner I (f/m/d), 80-100%

We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline of new and innovative products.

Position summary

The function holder is responsible for the support of Local Quality Owners and the QA oversight of a selected Portfolio of (Combination-) Products manufactured at the J&J IM Schaffhausen site.

Principal responsibilities
- Contact for internal and external stakeholders (operations, planning, logistics, engineering, etc.) within cross-functional teams in terms of Quality and Compliance.
- Investigation lead for non-conformances including CPA determination with respective Operations counterparts
- In-time release of parenteral products (intermediate and finished products)
- Proactive risk identification and mitigation
- Review and approval of non-conformance records and change control requests
- Review and approval of GMP critical SAP master data (e. g. bill of material, manufacturing instructions etc.)
- Review and approval of work instructions and standard operating procedures
- Review of Annual Product Reviews

**Qualifications**:

- A minimum of a Bachelor’s degree, preferably in a technical/scientific field.
- Experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role.
- Basic Understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes.
- Knowledge about GMP standards, policies and procedures and regulatory guidelines preferred
- Advanced communication skills, verbal and written in both English and German

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.

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