Job Description - Junior Local Quality Owner I (f/m/d), 80-100% (2406227451W)
Junior Local Quality Owner I (f/m/d), 80-100%
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
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
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.
* 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.
At Johnson & Johnson, we all belong
Primary Location
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.
#J-18808-Ljbffr