Quality System Specialist in Bern

At Consultys Switzerland, we empower Life Sciences innovation. We are offering a permanent opportunity for a Quality Systems Specialist (GMP) to support key quality activities in a regulated environment, contributing to compliance, continuous improvement, and operational excellence within the pharmaceutical, chemical, or food manufacturing industry.

Your Role :

As a Quality Systems Specialist, you will support quality assurance activities related to deviations, change controls, documentation management, and risk assessments. You will work closely with cross-functional stakeholders to ensure GMP compliance and drive effective quality processes across the organization.

Your Responsibilities

• Investigate quality deviations and prepare deviation reports.
• Create and manage change requests, coordinate required actions, and monitor implementation progress.
• Draft, review, and update SOPs, procedures, and work instructions.
• Conduct risk assessments and risk analyses (FMEA and similar methodologies).
• Ensure all quality system activities comply with GMP requirements.
• Collaborate with stakeholders across departments to support quality and compliance initiatives.
• Contribute to continuous improvement of quality processes and documentation.

Your Profile

• Degree in a scientific discipline such as Pharmacy, Chemistry, Biology, or a related field, or equivalent professional experience.
• Initial experience within the pharmaceutical, chemical, or food industry in a GMP-regulated environment.
• Practical experience in at least one of the following areas: deviations, change control, documentation management, SOP writing, or risk management.
• Ability to work independently and quickly understand new topics and processes.
• Strong communication skills with the ability to engage stakeholders effectively.
• Team-oriented mindset and collaborative approach.
• Fluent German (C2 level or equivalent) is mandatory.

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