Responsibilities & Accountabilities:
The Analyst 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. The Analyst also coordinates the stability testing of COVID-19 Vaccine according local procedures and agreed timelines.
The Analyst is a subject matter expert on release and stability processes and has a leading role during the GMP inspections. He/she joins meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless customer experience.
The Analyst is responsible to coordinate all Data Requests provided by various stakeholders (RA; Health Authority; DPDS etc) and has the accountability to plan, organize, prioritize and execute the Data Requests based on the stakeholder requests. The Analyst has affinity and motivation to lean the process continuously and to apply Business Excellence and Faster Forward tools on a day-to-day basis.
- Education minimum relevant Bachelor / HBO degree
- At least 3 years of work experience in the pharmaceutical / GMP 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 regarding data integrity and data management (eg. eLIMS)