External Manufacturing Operations Support

vor 1 Woche

Fribourg, Schweiz Expleo Vollzeit

Overview:

- Expleo offers a unique range of integrated engineering, quality, and strategic consulting services for digital transformation. Against a backdrop of unprecedented technological acceleration, we are the trusted partner for innovative companies. We help them develop a competitive advantage and improve the daily lives of millions of people._

To support our growth in Switzerland, we are looking for a consultant:
**External Manufacturing Operations Support**:
As part of our global external manufacturing network, we are looking for a consultant to join us as **External Manufacturing Operations Support (EMOS)**. In this transversal role, you will contribute to the performance of Contract Manufacturing Organizations (CMOs) and strategic suppliers by supporting the External Manufacturing Operations Leads (EMOLs).

The EMOS will act as a key partner to ensure smooth execution of administrative, quality, and operational tasks, enabling the EMOLs to focus on strategic collaboration with external partners. This position offers a unique opportunity to gain broad exposure to global pharmaceutical operations, GMP requirements, and cross-functional collaboration.

**Key Responsibilities**:
- Support EMOLs with Change Control activities: drafting proposals, encoding in eQMS, and ensuring timely follow-up.- Review investigation reports and maintain accurate documentation in the electronic Quality Management System.- Prepare communications, notifications, and updates to CMOs and vendors.- Manage purchase orders and maintain budget trackers.- Coordinate performance reviews, Operational Management Review (OMR) calendars, and Business & Operations Plans (BOP).- Contribute to monthly KPI tracking and bi-annual External Network Risk Reviews.- Ensure effective planning, execution, and closure of administrative activities to facilitate seamless collaboration with CMOs and CDMOs.- Where appropriate, take ownership of small-scale projects, investigations, or specific Change Controls.- Act as a backup to EMOLs during short-term absences and manage basic communications with CMOs when needed.

**Profile**:
- Academic background in life sciences, engineering, business, or a related field.- First experience in the **pharmaceutical, biotech, or manufacturing sector** is an advantage, but not mandatory.- Knowledge of **GMP regulations, Change Control processes, and root cause analysis** is a plus.- Strong organizational and analytical skills, with the ability to manage several priorities at once.- Able to work independently, take initiative, and propose solutions.- Excellent communication and interpersonal skills, with fluency in English (spoken and written). Additional languages are a plus.- Comfortable collaborating in a multicultural, cross-functional environment.- Strong results orientation and interest in technical and manufacturing operations.

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