Contract

Change Control Manager (m/f/d)

Change Control Manager (m/f/d) – Change Management / ISO 13485 / FDA 21 / English / German


Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Change Control Manager (m/f/d)


Background:

Global Operations Consumables is the competence center for single-use injection molded parts in the diagnostic workflow. This includes the development of new consumables, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement. It has expertise in all injection molding and plastic-relevant areas: Mold technology, polymers, automation, product design, supplier management, injection molding technique, plastics technology and material sciences.

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:

  • B.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 (ISO 13485, FDA 21 CFR 820, IVDR/MDR)
    * First professional experience in document management within a regulated environment
    * Good knowledge in SAP or comparable ERP system
    * Very good user skills in MS Office and Google applications
    * Very good communication skills in German and English (spoken and written) are required
    * Team player, independent and reliable way of working is expected.

Reference Nr.: 923055TP
Role: Change Control Manager (m/f/d)
Industrie: Pharma
Workplace:
Rotkreuz
Pensum: 70-100%
Start: 01.04.24

Duration: 12++
Deadline: 15.02.2024


If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.

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Role details

Industry Pharmaceuticals
Location Zug
Type Contract
Skill Change Control Manager (m/f/d) - Change Management / ISO 13485 / FDA 21 / English / German
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