Specialist QA Release

"Caring for the world… one 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.

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!

The QA Specialist performs quality activities in support of new and existing products. The position has a great deal of interaction with many internal departments, including Planning, Manufacturing, Quality Control, and local/global Stakeholders. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements, such as Maintain processes to ensure high quality products and compliance with current standards; documentation reviews; support quality audits; and data analysis

Specialist QA Release

(Fixed-Term Contract)

Specific Responsibilities:

• Execute proper review of batch record documentation for Incoming Products, Bulk, Intermediate and Finished Good products for accuracy and completeness to ensure compliance with GMP regulations and all applicable internal procedures and policies.
• Coordinate all activities related to batch record review and batch release with internal and external Quality, Planning and Quality Control teams within Janssen Supply Chain.
• Execute batch release for Incoming Products, Bulk, Intermediate and Finished Good products as a delegate of local Qualified Person to ensure compliance with GMP regulations and all applicable internal procedures and policies.
• Issue non-conformances records from batch review and release process and report them to quality organization and supply chain stakeholder.
• Develop a common understanding of the entire batch release process for products in scope of the site.
• Support internal, external, and third-party audits.
• Support in projects and/or investigations, including process improvement activities