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J&J Family of Companies Area Quality Owner in Schaffhausen, Switzerland

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

Area Quality Owner (AQO) (m/f)

We manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). 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:

As an AQO you will join a diverse team and amongst others be responsible for Quality and aseptic oversight of equipment and premises used for parenteral manufacturing at the JSC Schaffhausen site in the Business Units Parenterals and Optical Inspection & Device Assembly Packaging departments.

Responsibilities

  • Provide Quality and Compliance guidance to assigned departments

  • Perform Quality and aseptic oversight on the shop floor

  • Active contribution to new concepts and projects as well as suggestions for improvement in the above-mentioned areas

  • Proactive risk mitigation

  • Assessment and approval of Quality issues/ investigations (QIs) and CPAs related to utilities, facility, environment and equipment. Investigation quality lead for major non-conformances (deviations)

  • Review and approval of Protocol, Reports, SOPs/WIs, Change requests (COCs) and further documents

  • Review and approval of GMP critical SAP master data (e. g. manufacturing instructions)

  • Support of ‚customers‘ (Production, Logistics, Technical operations, Engineering, etc.) in terms of GMP Compliance

  • Participation as Subject Matter Expert in Health Authority inspections and audits

Qualifikationen

  • Bachelor or Master Degree in a microbiological, technical or science field

  • Proven experience (5 yrs) in a GMP regulated aseptic Pharma production environment or experience in a relevant Quality role (3 yrs)

  • Strong technical and process background in sterile fill and finish production

  • Strong knowledge in aseptic processing required

  • Experience as team or project lead preferred

  • Advanced skills in German and English (oral and written)

You are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal 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

Requisition ID

2105942299W

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