Quality Specialist - 7069

CTC Resourcing Solutions; Oberwallis; Vor Ort; CHF 70.000 - 100.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions seeks a Quality Specialist for a 4-month contract located in Visp, Switzerland. The role supports GMP-related Change Requests and Concept Changes within the Supply Chain, ensuring proper documentation, approval, and closure in line with QMS requirements.

The ideal candidate will coordinate with Quality Assurance, Manufacturing and IT, handling impact and risk assessments, governance activities, and continuous improvement of quality processes.

Qualifikationen

• Experience with GMP quality systems and documentation standards.
• Strong stakeholder management and cross-functional collaboration.
• Ability to work independently with limited supervision.
• Excellent analytical and problem-solving skills.

Aufgaben

• Coordinate GMP-related Change Requests and Concept Changes in TrackWise.
• Ensure changes are documented, reviewed, approved, implemented and closed per GMP/QMS requirements.
• Collaborate with Supply Chain, QA, Manufacturing, Engineering, IT and others for impact/risk assessments.
• Monitor progress of change activities and drive timely closure of records.
• Develop and maintain standard procedures and work instructions for change management.

Kenntnisse

Stakeholder management

Cross-functional collaboration

Analytical skills

Independent work

Communication skills

Tools

TrackWise

Jobbeschreibung

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is recruiting for a Quality Specialist for a 4-month contract until 31st December with extension possible.

This is an onsite role based in Visp, Switzerland.

The Quality Specialist supports the Supply Chain organization in the compliant and efficient management of GMP-related Change Requests and Concept Changes.

The role coordinates change activities in TrackWise, supports impact and risk assessments, and ensures appropriate documentation, approval, implementation, and closure in line with Quality Management System requirements.

Main Responsibilities:

• Coordinate and support the end-to-end management of GMP-related Change Requests and Concept Changes in TrackWise.
• Ensure changes are appropriately assessed, documented, reviewed, approved, implemented, and closed according to applicable GMP and QMS requirements.
• Partner with Supply Chain, Quality Assurance, Manufacturing, Engineering, IT, and other stakeholders to complete impact assessments, risk assessments, and implementation planning.
• Monitor progress of open change activities, proactively follow up on actions, and support timely closure of records.
• Develop, document, and maintain standardized procedures, operating standards, and work instructions for recurring Supply Chain change management activities.
• Capture lessons learned and best practices while managing different types of Change Requests and Concept Changes, translating them into clear and sustainable ways of working.
• Support governance activities, reporting, and metrics related to change management and supply chain quality processes.
• Provide guidance to stakeholders on TrackWise workflows, documentation expectations, and approved ways of working.
• Identify opportunities to simplify, harmonize, and continuously improve quality-related Supply Chain processes.
• Support audit and inspection readiness activities related to change management, documentation, and quality systems.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Experience managing Change Requests, Concept Changes, Change Controls, Deviations, CAPAs, or related GMP quality processes.
• Hands-on TrackWise software experience is highly valuated.
• Good understanding of Quality Management Systems, GMP requirements, and documentation standards.
• Experience developing or maintaining procedures, work instructions, standards, or business process documentation.
• Quality Assurance or Quality Systems background is highly valued.
• Strong stakeholder management, facilitation, and cross-functional collaboration skills.
• Ability to work independently in a remote setup and drive activities with limited supervision.
• Strong organizational, analytical, follow-up, and communication skills.