Job Detail

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 API (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 Active Pharmaceutical Ingredients (API) team.

 
 

POSITION SUMMARY:

The function holder is responsible for QA oversight for selected, chemically manufactured products at the JSC Schaffhausen site. This includes quality oversight for all relevant activities associated with API manufacturing, analytical testing and distribution. This includes the introduction of new chemical entities into the site.

 

Main responsibilities

• On-time release of clinical and commercial APIs and/or precursors for medical device


• Investigation lead for major non-conformances


• Review and approval of other non-conformances


• Investigate and manage Customer Complaints


• Review and approval of change control requests


• Review and approval of documents related to the lifecycle management of API (development reports, Criticality Analysis documents, validation documents, Continuous Process Verification documents, Master Batch Records, Product Quality Reviews)


• Maintain quality contact with external customers for which Cilag acts as contract manufacturer


• Review and approval of GMP critical SAP master data (e. g. shelf-life, date of manufacture, Detailed Material Description)


• Review and approval of work instructions and standard operating procedures


• Support and lead customer audits


• Support health authorities’ inspections (Swissmedic, US FDA)


• Issue, review and update of Quality Agreements


• Participation as QA representative in different projects


• Support of internal customers (production, logistics, engineering, etc.) in terms of GMP Compliance and Quality


• Proactive risk mitigation

Qualifications

• Master Degree in a technical or science discipline


• Minimum one (1) year of experience in a relevant quality role or two (2) years of experience in a GMP regulated API or Pharma production environment


• Strong background in regulatory guidelines preferred


• Knowledge in chemical manufacturing 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.




Primary Location

Switzerland-Schaffhausen-Schaffhausen-


Organization

Cilag AG (8562)


Job Function

Quality Assurance


Requisition ID

1905754788W