Specialist Quality Systems

Schaffhausen, Switzerland

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Quality

Quality Systems

Professional

The Q-Systems Specialist supports the Quality Systems team and the local Business Process Owner for key Quality Management System processes at the Schaffhausen site. The role contributes to compliant, efficient, and sustainable execution of Quality Systems processes, including Change Control, NC/CAPA, Commitments, Escalations, Risk Assessments, and related metrics. The position is expected to develop subject matter expertise in one assigned process area while maintaining active responsibilities and support across the other Quality Systems processes.

The role provides process and system support, end-user training, review board and alignment meeting organization, and continuous improvement input to strengthen compliance, inspection readiness, and user capability across the organization.

• Develop and maintain subject matter expertise for one assigned Quality Systems process, while providing support, process guidance, system support, governance input, metrics review, and continuous improvement contributions across Change Control, NC/CAPA, Commitments, Escalations, and related quality metrics.
• Provide day-to-day support, troubleshooting, coaching, and training for end-users across relevant Quality Systems processes.
• Organize and support review boards and alignment meetings for relevant Quality Systems processes, including process performance monitoring, KPI reviews, and timely follow-up on overdue or at-risk records.
• Support the local Business Process Owner in implementing global and local projects, process enhancements, and system improvements related to Quality Systems processes.
• Maintain active involvement in multiple Quality Systems processes, including Change Control, NC/CAPA, Commitments, Escalations, and quality metrics, with responsibilities assigned based on business needs and process priorities.
• Contribute to audit and inspection readiness as Quality Systems subject matter expert for the assigned process area and support other Quality Systems topics as needed.
• Maintain compliance with applicable company procedures, GMP, and regulatory requirements.

• Bachelor’s degree in a scientific, technical, pharmaceutical, engineering, or related field, or equivalent relevant experience.
• Relevant experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or similarly regulated environment.
• Strong understanding of Quality Systems processes, with demonstrated experience in one or more related areas such as Change Control, Non-Conformance, CAPA, Risk Assessments, Commitment Records, Escalations, and quality metrics, and willingness to develop into a subject matter expert for an assigned process area.
• Experience working with computerized quality management systems and supporting end-users in system or process-related questions.
• Strong verbal and written communication skills, with the ability to interact effectively with cross-functional stakeholders.
• Ability to work independently with limited supervision, manage priorities, meet deadlines, and maintain a positive and solution-oriented mindset.
• Fluency in English;
  German language skills are a plus, with willingness to improve German proficiency.

• Team-oriented,…