Senior Local Quality Owner.

☞ Johnson & Johnson

View: 135

Update day: 25-04-2024

Location: Schaffhausen Schaffhausen SH

Category: Sales

Industry: Medical Equipment Manufacturing Hospitals Health Care Pharmaceutical Manufacturing

Job type: Full-time

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Job content

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 (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.

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
  • 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
  • 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.

Primary Location

Switzerland-Schaffhausen-Schaffhausen-

Organization

Cilag AG (8562)

Job Function

Quality

Requisition ID

2206027002W

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Deadline: 09-06-2024

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