Quality System Specialist

Consultys Suisse; Bern; On-site; CHF 100,000 - 140,000; Full time

Job summary

Consultys Suisse is seeking a Quality Systems Specialist (GMP) in Switzerland to support deviations, change controls, documentation management, and risk assessments. You will work with cross-functional teams to uphold GMP compliance and drive quality improvements across the organization.

The role requires a degree in a scientific field and prior GMP experience in pharma/chemical/food industries. German fluency at C2 level is mandatory to engage stakeholders effectively.

Qualifications

• Degree in a scientific discipline or equivalent professional experience.
• Initial experience in GMP-regulated pharmaceutical/chemical/food industry.
• Experience with deviations, change control, documentation management, SOP writing or risk management.
• Ability to work independently and grasp new topics quickly.
• Strong communication and stakeholder engagement abilities.

Responsibilities

• Investigate quality deviations and prepare deviation reports.
• Create and manage change requests, coordinate actions, and monitor implementation.
• 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.

Skills

GMP knowledge

Communication skills

Independent worker

Team player

Stakeholder engagement

Education

Degree in Pharmacy, Chemistry, Biology or related field

Tools

SOP drafting

Deviation/Change control

Documentation management

Risk assessment (FMEA)

Job description

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.