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Cilag AG in Schaffhausen, Switzerland is part of the Johnson & Johnson Innovative Medicine (J&J IM) Supply Chain organization and is currently recruiting for a

Junior Local Quality Owner I (f/m/d), 80-100%

We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline of new and innovative products.

Position summary

The function holder is responsible for the support of Local Quality Owners and the QA oversight of a selected Portfolio of (Combination-) Products manufactured at the J&J IM Schaffhausen site.

Principal responsibilities

• Contact for internal and external stakeholders (operations, planning, logistics, engineering, etc.) within cross-functional teams in terms of Quality and Compliance.
• Investigation lead for non-conformances including CPA determination with respective Operations counterparts
• In-time release of parenteral products (intermediate and finished products)
• Proactive risk identification and mitigation
• Review and approval of non-conformance 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
• Review of Annual Product Reviews

Qualifications

• A minimum of a Bachelor’s degree, preferably in a technical/scientific field.
• Experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role.
• Basic Understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes.
• Knowledge about GMP standards, policies and procedures and regulatory guidelines preferred
• Advanced communication skills, verbal and written in both English and German

We are seeking a dynamic and solution-oriented individual eager to contribute to our team and drive success in a collaborative, international, and fast-paced environment. This role offers the opportunity for growth and development, and if you believe it aligns with your skills and aspirations, we encourage you to submit your application materials without hesitation.

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