Do you want to be the Analyst that will be responsible for the release and stability coordination for commercial product coordination?
For our team we are looking for an analyst that will be responsible for the release and stability coordination and single point of contact for commercial product coordination within Leiden QC.
Your responsibilities and accountabilities are:
- You coordinate 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.
- You coordinate the stability testing of JSC large molecule products according local procedures and agreed timelines.
- You are a subject matter expert on release and stability processes and you have a leading role during the GMP inspections.
- Youi will join meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience
- You are responsible to coordinate all data requests provided by various stakeholders (RA; Health Authority; DPDS etc) and you have the accountability to plan, organize, prioritize and execute the Data Requests based on the stakeholder requests.
- You have affinity and motivation to lean the process continuously and to apply Business Excellence and Faster Forward tools.
- Education minimum relevant HBO diploma
- At least 3 years of work experience in the pharmaceutical environment
- Excellent interpersonal and organizational skills
- Excellent communication skills (oral and written English)
- A quality, compliance and business minded attitude and flexibility
- Knowledge and Affinity with Business Excellence tools and Faster Forward mindset
- Flexible and agile, capable of handling multiple requests and changing priorities
- Proficient in the use of lab systems & lab environment, particularly around data integrity and data management (eg. eLIMS)
A great job oppurtunity at one of the leading companies in healthcare.
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: email@example.com Kenmerk: 9436.