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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
Local Quality Owner Late Stage & Value Optimizer (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 accelerating growth in parenterals, supported by an impressive pipeline of new and innovative products.
Position summary
The function holder is responsible for the QA oversight of a selected Portfolio of established (Combination-) Products, which are manufactured at the J&J IM Schaffhausen site.
Principal responsibilities
- Key Contact for internal and external stakeholders (operations, planning, logistics, engineering, regulatory affairs etc.) within cross-functional teams in terms of Quality and Compliance.
- Q&C contributions including Decision making and problem solving and oversight of assigned, established manufacturing lines.
- Investigation lead for major non-conformances (deviations) including CAPA alignment with Operations counterparts.
- In-time release of parenteral products (intermediate and finished products).
- Proactive risk mitigation.
- Review and approval of non-conformances (deviations) records and change 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.
- Support of cross-functional and global projects.
- Review of Annual Product Reviews.
Qualifications
- A minimum of a Bachelor’s degree, preferably in a technical/scientific field. A Master’s degree or advanced is desirable.
- Minimum of 5 years of experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role.
- Strong understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes.
- In-depth knowledge in GMP standards, policies and procedures
- Knowledge about regulatory guidelines preferred
- Advanced communication skills, verbal and written in both English and German
We are looking for a dynamic and solution-oriented individual eager to contribute to our team and drive success in a collaborative, international and fast-paced environment. If you see yourself in this role, we encourage you to share your application materials with us without hesitation.