As SME Plasma Qualification you manage the process of plasma qualification (supplier & plasma specifications & requirements, supplier auditing, quality agreements, metrics & supplier evaluation) of all plasma being supplied to and processed at Prothya Biosolutions. You would be responsible whether it is sourced internally or externally, complies to quality standards, regulations and guidelines while taking into account commercial business aspects. The goal is to increase the processability of the plasma yet still guaranteeing that intermediates and medicinal products derived from that plasma are qualitatively correct and safe for patients.
Your job
- You setup, plan and maintain a plasma source inspection & audit process to keep plasma sources qualified. Equally, you set up and maintain plasma quality agreements and make sure plasma supplies are compliant to these requirements.
- In this capacity, you act as POC to Prothya quality organization where execution of audits and inspections resides.
- Naturally, you ensure Plasma source compliance to US/EU guidelines & directives and local legislation together with your colleague SME Plasma Vigilance.
- You asses and implement consequences of updated guidelines and regulations. Afterwards, you are responsible for setting up and implementing E2E process on the handling of customer notifications.
- You define and maintain metrics and performance indicators on plasma and plasma suppliers, evaluate internal and external plasma & plasma suppliers and report of metrics to stakeholders
- With your professionalism you maintain a culture of accountability within the company that enables continuous improvement ensuring compliance, safety, quality and usability of plasma supplied.
Your profile
- Relevant Bachelor or Master Degree (e.g. Engineering, Bio-Chemistry, Pharmacy)
- Experience of quality (assurance, control, management) in an operational role in the bio-pharmaceutical industry
- Experience plasma management (cold chain logistics, processability, quality)
- Experience with quality management system elements like deviations, Change Control, CAPA’s, Change Notifications, Quality agreements, TrackWise & doccompliance
- Experience with relevant (international) regulations & guidelines, compliance and inspections by the EU and US authorities
- You are proficient in MS Office applications, specifically Share point, Word, Excel, Powerpoint
- You are entrepreneurial and operate comfortably in new business environments and can work independently by taking ownership.
- You are analytical, good at solving problems and have excellent verbal & documentation skills.
- You are result-oriented and decisive and have the ability to balance quality & business aspects
- You are fluent in English
Our offer
We offer you a fulltime position with the following employment conditions:
- A market-rate salary
- A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
- A fulltime employment of 40 hours per week
- Flexible working hours after deliberation
- Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
- Good accessibility by public transport and we provide private parking;
- Sound pension provision.
More info
If you would like to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your resume and motivation via the apply button on this page. We aim to respond to you within a week.
