GMP QA Specialist: Deviations, Change Control & QMS

Swisslinx AG

Bern

Remote

CHF 100,000 - 145,000

Part time

3 days ago
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Job summary

Swisslinx AG in Bern is seeking two GMP Compliance Specialists to support deviation management, change control, documentation and risk assessments within a GMP-regulated environment.

The roles start on 1 December 2026, run for about seven months, with a workload of 100% (41 hours per week) and possible remote work. Two positions available; ideal candidates have a life sciences degree or relevant GMP experience and strong English (C2).

Qualifications

  • Investigate deviations and prepare deviation reports.
  • Create and coordinate change requests, ensuring timely follow-up of required actions.
  • Create and update SOPs, procedures and work instructions.
  • Conduct risk assessments, including FMEA.

Responsibilities

  • Support deviation management, change control, documentation and risk assessments within GMP environment.
  • Coordinate change requests and follow-up actions with stakeholders.
  • Contribute to SOP documentation and risk assessments, ensuring accuracy and compliance.

Skills

Deviation management
Change control
SOP documentation
Risk assessment
GMP experience
Stakeholder engagement
English C2
Independent working

Education

Life Sciences degree

Job description

Swisslinx AG in Bern is seeking two GMP Compliance Specialists to support deviation management, change control, documentation and risk assessments within a GMP-regulated environment.

The roles start on 1 December 2026, run for about seven months, with a workload of 100% (41 hours per week) and possible remote work. Two positions available; ideal candidates have a life sciences degree or relevant GMP experience and strong English (C2).

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