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Job Function:
QualityJob Sub Function:
Quality SystemsJob Category:
ProfessionalAll Job Posting Locations:
Schaffhausen, SwitzerlandJob Description:
Specialist Quality Systems
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.
Shape guidance principles for NC/CAPA and Change Control Risk Assessments and provide face-to-face training for NC/CAPA and Change Control (Risk Assessments).
Act as the go-to person for Risk Assessment leads regarding the NC/CAPA and Change Control process.
Act as the Investigation Owner for any nonconformities that arise within the Q-Systems Team in Schaffhausen.
Rotating responsibility to host the NC/CAPA Review Meeting as well as CAPA Review Board and Change Control Review Board for the site.
Represent the site in global councils/projects and shape the quality system environment.
Participate as Subject Matter Expert in Health Authority inspections and audits.
Contribute to innovative 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 a highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.
Minimum Qualification
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 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.
You are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills. 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. To ensure a fair recruitment process, please refrain from adding a photo in your CV
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