Job Description - 2 x Local Quality Owner Launch & Grow / NPI (f/m/d), 80-100% (2406227450W)
Cilag AG in Schaffhausen, Switzerland is part of the Johnson & Johnson Innovative Medicine (J&J IM) Supply Chain organization and is currently recruiting for:
2 x Local Quality Owner Launch & Grow / NPI (f/m/d), 80-100%
The function holder is responsible for the QA oversight of a selected Portfolio of (Combination-) Products for parenteral New Product Introductions (NPI) manufactured at the J&J IM Schaffhausen site.
Key Responsibilities
* Key Contact for internal and external stakeholders (operations, planning, logistics, engineering, etc.) within cross-functional teams in terms of Quality and Compliance.
* Q&C contributions including Decision making and problem solving and oversight of assigned qualifications and validations of NPI running on new manufacturing lines.
* Investigation lead for major non-conformances (deviations) including CPA alignment with Operations counterparts.
* In-time release of parenteral products (intermediate and finished products).
* 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.
* 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 degree 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 including 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.
Inclusion and Diversity
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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