Johnson & Johnson Careers

Local Quality Owner

Schaffhausen, Switzerland
Quality (Generalist)


Job Description

Requisition ID: 1805692152W

Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson and is currently recruiting for a
 
Product Life Cycle Manager / Local Quality Owner (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.

 

POSITION SUMMARY:
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.
 
Main responsibilities
  • Local life cycle management of parenteral 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

Qualifications
Your Profil
  • Master Degree in a technical or science discipline
  • Five years of experience in a GMP regulated Pharma production environment or three 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.

Primary Location
Switzerland-Schaffhausen-Schaffhausen-
Organization
Cilag AG (8562)
Job Function
Quality (Generalist)
Requisition ID
1805692152W