Johnson & Johnson is currently seeking a Specialist Quality Systems (m/f/d) to join our team located in Schaffhausen, Switzerland.
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/ .Position Summary As a Specialist in Quality Systems, you will join a diverse team and be responsible for Quality and Compliance in the framework of Quality Systems at the IM Schaffhausen site.Responsibilities Act as a Subject Matter Expert/Site Key User for Non-Conformances and CAPAs, Change Controls, and other related processes.Act as a Subject Matter Expert for Metrics related to Q-Systems processes.Provide end-user support for the site e.G.
Training, System Access Management, ad-hoc support.Rotating responsibility to host the site CAPA Review Board and Change Control Review Board and collect related Metrics.Represent the site in global councils/projects and shape the quality system environment.Participation as Subject Matter Expert in Health Authority inspections and audits.Innovate solutions to quality system gaps and lead continuous improvement projects regarding standardization, simplification, and digitalization to drive compliance and/or efficiency.Support the development and introduction of new processes and procedures.Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.Qualifications Minimum bachelor's degree in a science or technical field.Proven experience in a GMP Environment.Knowledge about basic Q-Systems processes, especially of Nonconformances & Change Controls.Strong communication (verbal & written) and interpersonal skills, self-awareness and flexibility required.Fluency in written and spoken English, with German language skills considered as an advantage.Team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills.Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.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.A cover letter is not required for your application, but we kindly ask that you include a brief statement explaining why you are applying in your resume or CV.
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