Change Control Manager

Change Control Manager - Engineering/Change Management/GxP/Project Management

Project Background:

Global External Manufacturing is the competence center for parts and products in the diagnostic
workflow, manufactured by external suppliers. This includes the development of new products,
product care activities, the assurance of supply as well as the supplier selection and
maintenance in close collaboration with Procurement.

The perfect candidate is someone who has knowledge and experience in GMP regulations and
practices. Furthermore the candidate demonstrates flexibility, adaptability, proactivity and
process thinking.

Tasks & Responsibilities:

• Managing change execution and change Coordination in the area of Global Operations Consumables with internal stakeholders (e.g. Quality Management) and external contract manufacturers
• Responsible for the efficient implementation of changes within Roche and also at the the contract manufacturer
• Responsible for compliance application of the change and the corresponding KPIs
• Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change
• Notification, Design Master Record, Design History File etc.
• Planning and implementation of work packages from product care projects with minimal supervision
• Being a proactive member of the squad
• Identification of process improvements in the working area (e.g. change process)

Must Haves:

• Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
• Work experience in change management or in project and process management
• Practical experience in a regulated GxP environment, ideally in medical devices/IVD industry
• First professional experience in document management within a regulated environment
• Good knowledge in SAP or comparable ERP system

Languages:

• German fluent (C1 / C2 Level)
• Englisch fluent (C1 / C2 Level)

Reference Nr.: 924019FC

Role: Change Control Manager

Industry: Pharma

Work Location: Rotkreuz

Workload: 70 - 100%

Start: 01.05.2025

Dauer: 12 Monate

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com. Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us:

ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult specializes in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we understand what it means to be professionally supported in your search for a new project and being employed.