Schaffhausen, CHE
6 days ago
Local Quality Owner
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. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job Category:** Professional **All Job Posting Locations:** Schaffhausen, Switzerland **Job 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. Learn more at https://www.jnj.com/ . **Local Quality Owner 80-100%** **Join Our Dynamic Team as a Local Quality Owner in Synthetics Manufacturing** Are you passionate about quality and compliance? We want you to help us uphold our commitment to excellence at Johnson & Johnson. As our Local Quality Owner (LQO), you will play a crucial role in ensuring our manufactured products meet Health Authority (HA) regulations and Johnson & Johnson standards. Key responsibilities include ensuring compliance with HA regulations, J&J standards, and cGMP guidelines; promptly processing and completing NCs, CPAs, Corrections, and Criticality Analysis documents; opening, assessing, and approving CoCs; and reviewing Quality Agreements (Internal/External) along with approving Product Quality Reviews (PQRs/APRs). You will also manage returns and complaints effectively, provide QA support for qualifications, validations, and project workshops, and edit, review, and approve documents in TruVault. Additional tasks include ensuring inspection readiness, participating in audits, approving Master Batch Records, executing timely disposition decisions for manufactured batches and restriction management for purchased and manufactured intermediate products, driving quality oversight activities, supporting other departments on cGMP compliance, and representing the site at global meetings. Furthermore, delivering on any tasks delegated by the Supervisor. **Why Join Us?** + Work in a collaborative environment where every voice matters. + Contribute to meaningful projects in Synthetics Manufacturing. + Enjoy opportunities for personal and professional growth. **Additional Details:** + Completed studies in the natural sciences or technical field, master school or higher specialized training, or equivalent professional experience (2-3 years in the pharmaceutical field). Professional experience in a GMP environment. + Advanced GMP knowledge and understanding of ICH, EMA, and FDA quality guidelines. + Excellent verbal and written communication skills in English and German, including the ability to effectively communicate with internal and external customers. + Strong analytical skills to identify gaps and root causes, with the ability to think outside the box to develop solutions. + Ability to work independently with minimal direction to meet tight deadlines + Beneficial background in Quality & Compliance functions, JJIM (Pharma) Manufacturing Operations, or MSAT. 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. If you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. 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.
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