Global Technical Sme, Upi, Da

vor 5 Monaten

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

**About** the role**:

- Act as technical Global Subject Matter Expert (SME) and 3rd level support for UPI (Serialisation and track and trace), digital authentication (Systech Unisecure), Systech insight to be implemented in our internal sites
- Drive innovation by identifying and implementing new technical solutions, technologies and improvements
- Maintain technical specifications on global level and standardization of the solutions across Takeda, as representative of the Global System Owner
- Ensure compliance in collaboration with “Head of Compliance Services Operational Technology - OT”
- Ensure compliance with the alert management and alert response time mandated by external/legal regulation and internal procedures as outlined in Takeda’s global procedures (SOP-223840 - Global SOP, Handling EU FMD, USA DSCSA and Digital Authentication Alerts).

**How you will contribute**:

- Ensure that global documentation is available and ready for use in all Takeda implementations and rool outs of the systems
- Ensure that the regulations are technically translated into technical specification to allow the site systems (L3, L2) to perform the packaging processes
- Provide technical and test expertise for the sites to develop their own implementation strategies
- Run regular review meetings with site contacts and supplier to review status, activities, Root cause and corrective actions for technical incidents. Define and agree on priorities of resolution. Escalate those to line manager if major risk to supply occurs.
- Provide feedback and improve service level in collaboration with supplier and support the preparation and execution of business review meetings with Systech
- Organize and maintain CoP/CoE
- Ensure compliance of SOP-223840 with current and emerging regulatory requirements
- Own the alert management process incl. the future outsourcing of the alert management process to TBS, support during audits

**_ DIMENSIONS AND ASPECTS _**

**Technical/Functional (Line) Expertise**
- Expert in quality management process such as CAPA, Deviation, investigation of root cause and Change Control;
- Knowledge about business use of serialization systems, including also vision tools and track and trace (aggregation)

**Leadership**
- Demonstrate TAKEDA leadership behaviors (strategic enterprise thinking, inspires and enables people, focus on the few priorities, elevates the capabilities of the organization)

**Decision-making and Autonomy**
- Demonstrates strong business acumen in making decisions based on Takedas Core values and in line PTRB

**Interaction**
- competent networker and effective collaborator across the Takeda organisation, especially with Quality organisation, supplier, site operations functions

**Innovation**
- Ability to work in changing environments
- Opened to work under pressure and in different ways when required
- Ability to overcome with creative solutions compliant with regulations and quality standards when required.

**Complexity**
- Has demonstrated ability to handle complex multi-faceted issues. Has strong problem solving capability
- Ability to work in different cultures across the globe under packaging line level - Engineers, Project Managers, Site Quality representatives
- Ability to coordinate and work in matrixed organization in contribution with other company organizations and business units; i.e. DD&T, Quality Operations.
- Ability to coordinate vendor towards resolution of incidents related to the internal use of the systems under its scope.

**What you bring to Takeda**:
**Required**
- Knowledge about pharmaceutical production with strong focus on packaging and automation

**Preferred**
- Knowledge about pharmaceutical production with strong focus on packaging, automation and vision systems
- Fluent in English.

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

**Empowering our people to shine**:

- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, _or_ any other characteristic protected by law._

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full t

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