- Setup and maintain plasma and sample specifications, complying with US/EU guidelines & directives and local legislation;
- Asses and implement consequences of updated guidelines and regulations.
- Define and implement plasma testing strategy
- Collect, assess and report epidemiological data, e.g. for (EU-) Plasma Master File.
- Perform risk assessments for plasma, plasma pools, intermediates and final products
- Set up and implement E2E process on post donation notifications/look backs and customer notifications regarding plasma
- Define and maintain metrics and performance indicators on plasma and report of metrics to stakeholders
- Take part in evaluation of suppliers
- Ensure continuous improvement on Plasma Safety, Quality Control, Supply Reliability, Cost Control
- Setup, maintenance and updating of the Plasma Dossier and maintenance and updating of Plasma Master File(s)
- Is involved as SME in Plasma related meetings, boards and committees, Contract management (Supply agreement, Quality agreement, Logistic agreement)
- Maintains communication regarding plasma parameters with Suppliers, Plasma Customers, Commerce (CDMO/DP), Manufacturing (CDMO/DP), Quality, Regulatory and Supply Chain.
- At least 10 years of management experience in an operational role in the bio-pharmaceutical industry;
- At least 5 years experience in plasma management from collection to processing
- Experience with statistical evaluation and epidemiological assessment of plasma data and the reporting thereof
- Strong knowledge of relevant (international) regulatory guidelines.
- Experience with compliance and inspections by the EU and US authorities
- Strong analytical skills and problem-solving mindset
- Able to deal with multiple- and changing priorities
- Work independently and take ownership
- Good communications skills on all levels
- Fluent in English and/or Dutch
- Good scientific reporting skills
- Full-time employment
- 8.33% end of year bonus and 8.33% holiday allowance
- Flexible working hours in consultation
- Personal training budget of €2,000 per 3 years
- Contribution to travel expenses from the first kilometer
- Good accessibility by public transport and private parking
- Pension plan at Zorg & Welzijn
SME Plasma Vigilance - Amsterdam, Nederland - Prothya Biosolutions
Beschrijving
What you're going to do
As a Plasma Vigilance SME you will be the responsible for the vigilance of all incoming plasma, for both of our sites in Brussels and Amsterdam. You will be the SME for plasma-related projects and changes in plasma parameters, and the process owner for plasma and plasma sample specifications, epidemiology, plasma dossier and contents of Plasma Master File.
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