VAY – Human Factors Engineer – Support for Autoinjector and PFS / no

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Job Detail

  • Job ID 531080

Job Description

svg class=\»e-font-icon-svg e-fas-caret-down\» viewBox=\»0 0 320 512\» xmlns=\»http:\/\/www.w3.org\/2000\/svg\»path d=\»M31.3 192h257.3c17.8 0 26.7 21.5 14.1 34.1L174.1 354.8c-7.8 7.8-20.5 7.8-28.3 0L17.2 226.1C4.6 213.5 13.5 192 31.3 192z\»\/path\/svg
«,»library»:»fa-solid»},»toggle»:»burger»}» data-widget_type=»nav-menu.default»>GCP Inspection Management Framework Rollout and Change Management (remote) / no-835by GCP Inspection Management Framework rollout and Change Management (remote) / no-835in CH-BaselEmployment TypeFreelance or CH-PayrollWorkload100% Part time PorsitionStart23.06.2025End31.10.2025All – In / HourRate negotiableDeadline19.06.20 12:00 amTotal HoursGCP Inspection Management Framework rollout and Change Management (remote) / no-835IndustryCompany sizeFounded inPhoneShowPhoneShowEmailLocationCH-BaselWebsiteFor our customer located in Basel/remote, Switzerland we are currently looking for a: GCP Inspection Management Framework Rollout and Change Management [remote] (m/f/d)

  • Location: CH-Basel and remote
  • Workload: 100 % Part time Position
  • Branch: Pharma
  • Duration: 23.06.2025 – 31.10.2025
  • Contract: Freelancer or CH-Payroll

Tasks & ResponsibilitiesThe CQA team needs PJM and Change Management support to finalize the playbook, drive the playbook rollout within RDQ, and to support and drive change management with the cross-functional teams, with a target date to complete the process in October ’25.

  • Clinical Quality Assurance (CQA) plays a pivotal role in ensuring that clinical trials are conducted in compliance with regulatory requirements, internal policies, and ethical guidelines.
  • A key responsibility of the team includes the centralized governance of non-routine GCP Health Authorities (HA) inspections and the management of the inspection lifecycle.
  • To strengthen capabilities in HA GCP inspection management, the CQA team has formalized their approach into a framework.
  • CQA is now working on a playbook to summarize the framework, and tools. The Playbook will cover Planning, Knowledge Management, and Lifecycle Management with a specific focus on the inspection. The rollout of the Playbook will require a focused change management approach within CDA / RDQ and across Line Functions. Training of key roles will be required and targeted approaches to support Inspection Preparation teams to move into the defined ways of working.

Must Haves

  • Previous experience delivering project successfully in a large, complex and matrix-based pharmaceutical organization
  • Previous knowledge of organisation is strongly preferred
  • Strong ability to synthesize structure and produce customer focused communications, slide decks and simplify complex information
  • Great verbal and written communication skills in English
  • Stakeholder management skills
  • Good collaborative skills

Did we catch your interest?The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.Employment TypeFreelance or CH-PayrollWorkload100% Part time PorsitionStart23.06.2025End31.10.2025All-In / HourRate negotiableTotal HoursDeadline19.06.20 12:00 amGCP Inspection Management Framework rollout and Change Management (remote) / no-835IndustryCompany sizeFounded inPhonePhoneShowEmailLocationCH-BaselWebsiteGCP Inspection Management Framework Rollout and Change Management (remote) / no-835Attach CV/Profile *Work PermitDo You Have a Swiss Work Permit?Work Permit Expiration DatePlease tell us how you’ve heard from us?More InformationData protection *span class=»data-protection»
You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.
/span
» id=»form-field-field_fe7596f-0″ name=»form_fields[field_fe7596f]»> You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.Send ApplicationAttach CV/Profile *Choose a fileDo You Have a Swiss Work Permit? *Work Permit Expiration DatePlease tell us how you’ve heard from us?More InformationData protection *You agree that your data will be used to process your request. Further information and revocation instructions can be found in the privacy policy.

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