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Johnson & Johnson Karrieren

Local Quality Owner NPI

Schaffhausen, Schweiz
Quality Assurance


Arbeitsplatzbeschreibung

Requisition ID: 1905737133W

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 NPI (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 New Product Introduction (NPI) team.
 
POSITION SUMMARY:
The function holder is responsible for QA oversight for selected clinical and commercial 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
  • As a QA representative in different NPI projects you will support new products being introduced to the site; Tox and clinical early phase batch manufacturing, as well as technical batches, process validation batches and corresponding launches!
  • On-time release of clinical and commercial parenteral products (intermediate and finished products)
  • Proactive risk mitigation
  • Investigation lead for major non-conformances (medium/ high impact investigations)
  • Review and approval of non-conformances (low/ medium/ high impact investigations) 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, review and update of Quality Agreements
  • QA Production area responsible
  • Perform Q-Aseptic Oversight
  • QA support in different projects
  • Support of ‚customers‘ (production, logistics, engineering, etc.) in terms of  GMP Compliance
  • Review of Product Quality Reviews

Qualifikationen
  • Master Degree in a technical or science discipline
  • Minimum Five (5) years of experience in a GMP regulated Pharma production environment or three (3) 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
  • 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.
 

Primärer Standort
Schweiz-Schaffhausen-Schaffhausen-
Organisation
Cilag AG (8562)
Funktion
Quality Assurance
Requisition ID
1905737133W