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Originele vacaturetekst

Junior Release & Stability Coordinator - Quality Control (Yacht Life Sciences)

Yacht Life Sciences has a vacancy for a junior Release & Stability Coordinator to work at Janssen Biologics in Leiden.


Quality Control (QC) Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site belonging to the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise. All test laboratories are supported by the Release & Stability team, which is integrated by product E2E QC owners who lead and coordinate the release and stability testing processes for commercial products through deep expertise and effective communication between global stakeholders (e.g. DPDS, PQM, VPAD, VCM, CMOs, EQ) and Leiden QC. The Release & Stability team leads and supports complex non-conformances investigations, initiates improvements to optimize the testing strategy and execution, and owns the Life Cycle Management activities for the commercial products tested at Leiden QC.


Tasks and Responsibilities:

  • Fully owns end-to-end product testing process within Leiden QC
  • Coordinates the release of raw materials drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines. 
  • Coordinates the stability testing of JSC large molecule products according to local procedures and agreed timelines. 
  • Participates in meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience.
  • Responsible to coordinate all data requests provided by various stakeholders (e.g. RA. Health Authority, DPDS) and has the accountability to plan, organize, prioritize and execute the data Requests based on the stakeholder requests.
  • Responsible for reviewing the CPV plans and matrixes and update the QC release trend limits accordingly.
  • Provide input for the YBPR and APR requests.
  • Leads and drives continuous improvement projects.
  • Influences, develops and executes strategy for expertise area.
  • Proactively shares knowledge with team and other sites and functions to drive improvement and alignment.
  • Adhere to compliance best practices, EHSS regulations and lean principles.
  • Perform other work-related activities assigned by supervisor.
  • Maintain compliance with all company policies and procedures.
Uren:
40
Type vacature:
Intern

Over de werkgever

Janssen Biologics in Leiden. Janssen's work in the Netherlands covers almost everything involved in making medicines and vaccines: from research to disease prevention and from the development of new medicines to their production and marketing. We do this at four different locations. Janssen Biologics, one of our sites in Leiden, produces complex biological medicines and vaccines. 

Wat wij bieden

We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a secondment contract for 1 year via Yacht with an assignment at Janssen Biologics for at least 12 months. Salary is between 3500 and 4500 euro gross per 4 week period.

You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.

Vaardigheden

Qualifications:

  • Bachelor or Master degree in a relevant discipline with >2 years of relevant working experience
  • Experience in project management and working according to GMP
  • Experience with lab systems and lab environment, data integrity and data management
  • Experience with statistical data analyses
  • Lean/BE experience
  • Fluency in English

Opleiding

hbo

Wat wij bieden

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