Specialist Quality Systems

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Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Schaffhausen, Switzerland

Job 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 ski...