J&J Family of Companies Senior Local Quality Owner in Schaffhausen, Switzerland
Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a
Senior Local Quality Owner (m/f/d)
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.
The function holder is responsible for QA oversight for selected parenteral products manufactured at the JSC Schaffhausen site. This includes quality oversight for all relevant activities in sterile fill and finish, assembly and packaging of the respective combination products.
On-time release of parenteral products (intermediate and finished products)
Proactive risk mitigation
Investigation lead for major non-conformances (deviations)
Review and approval of non-conformances (deviations) 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
Issue and review of Quality Agreements
Support of projects
Support of ‚customers‘ (production, logistics, engineering, etc.) in terms of GMP Compliance.
Review of Product Quality Reviews
Master Degree in a technical or science discipline
Five to ten years of experience in a GMP regulated Pharma production environment or five years of experience in a relevant quality role
Strong background in regulatory guidelines preferred
Knowledge in aseptic processing preferred
Experience as team or project lead 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.
Cilag AG (8562)