GMP Quality Systems Specialist - Deviations & Change

Consultys Suisse

Bern

On-site

CHF 100,000 - 140,000

Full time

8 hours ago
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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

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.

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