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Johnson & Johnson Karrieren

Senior QA Specialist

Schaffhausen, Schweiz
Quality Assurance


Arbeitsplatzbeschreibung

Requisition ID: 1905714209W

Cilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain (JSC) organization, within Johnson & Johnson and is currently recruiting for a


 

Senior QA Specialist (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 and QA support in the area of aseptic parenteral production at the JSC Schaffhausen site. This includes quality oversight, handling of quality issues and corrective/preventive actions as well as review and approval of documents. Further, a fundamental part is collaboration in project teams in the areas of aseptic processing, environmental monitoring, utilities, hygiene, equipment process validation and aseptic process simulation (media fill) with the related departments. These tasks will be executed in shared responsibility and mutual representation within a small team of experts in the areas of oversight, aseptic processing and microbiology.
 
 
Main responsibilities
  • Quality Oversight in the aseptic production area, including organization, execution and trending
  • Communication of oversight results to supervisors, department heads and management
  • Aseptic operator training: planning, organization and execution of theoretical and practical training
  • Smoke Study accompaniment and definition of aseptic interventions
  • Support to and approval of quality issues, quality investigations and CAPAs
  • Review and approval of protocols, reports, SOPs, change requests and further documents
  • Active contribution to new concepts and various projects as well as suggestions for improvement in the above mentioned areas
  • Guidance in all questions regarding Aseptic Handling and related fields
  • Participation in Authority inspections and audits as Subject matter expert
  • Networking within JSC Schaffhausen and within the Johnson & Johnson Aseptic Processing Community

Qualifikationen
Your Profil
  • Master Degree in a microbiological, hygiene or related science discipline
  • 3-5 years of experience in a GMP regulated Pharma production environment or 2-3 years of experience in a relevant quality role
  • Pro-active attitude
  • Knowledge in aseptic processing preferred
  • Knowledge in regulatory requirements desirable
  • Experience as team or project lead desirable
  • Advanced communication skills in German and English (oral and written)
 
You are a team-oriented, open-minded, dynamic and highly motivated person with strong communication skills. For collaboration with different departments and different levels of responsibility you will need flexibility, social competence and a reasonable degree of authority. Your analytical thinking enables you to process complex tasks. You will take decisions independently and provide advice as needed.
 

Primärer Standort
Schweiz-Schaffhausen-Schaffhausen-
Organisation
Cilag AG (8562)
Funktion
Quality Assurance
Requisition ID
1905714209W