Coordinator - Release
Il y a 7 mois
**Position**: Coordinator Release**
Reports to the Lead Qualified Person
**Objectives**:
- Responsible for the coordination of all plasma-related activities, to ensure that all operations within the organization are carried out in a timely manner, as optimally as possible according to current GMP, and that quality is guaranteed throughout the entire process, from receipt of plasma units through to plasma batch release.
In short: To guarantee GMP compliance for every batch of plasma used or dispatched by PROTHYA.
**Key responsibilities and result areas**:
- ** Release**:To release each plasma batch autonomously and within the deadlines defined by the production orders in the SAP system or by the dispatch schedule to partners.
- ** Quality assurance**:Evaluate quality autonomously on the basis of priorities and risks, and in accordance with procedures, guidelines and deadlines, and determine actions to be taken, in order to guarantee the quality of release processes (follow-up of post-donation information, risk analysis in the event of lookbacks, release of plasma batches).
- ** Quality control**:Verify quality controls within its area of responsibility, in accordance with standards, procedures and directives, to ensure compliance with legal and recommended standards. Technical problems. Solve/treat complex quality problems, to ensure continuity and quality of production at all times.
- ** Projects**:Coordinate and/or participate in and report on large (medium-sized) projects, in accordance with the project manager's guidelines and current standards, in order to contribute to the smooth running of the project in line with the agreed quality, schedule and budget.
- ** Documentation**:Maintain, update, and communicate documentation related to the quality system, in order to contribute to the transfer of knowledge and guarantee the traceability and accuracy of data collected.
- ** Knowledge acquisition and diffusion**:Proactively monitor developments in own area of expertise, and acquire and share knowledge in this field, in order to translate these developments into accurate and relevant information for the organization.
- ** Various additional tasks**:Carry out various complementary tasks, either proactively or at the request of the line manager, to support the department, the Quality unit or other departments
**Profile**:
- Ability to build good relations with members of other departments.
- Ability to work closely with other members of the department.
- Good communicator, stress resistant and able to prioritize.
- Show initiative and be proactive.
- Ability to manage routine work without becoming bored.
- Ability to work independently, be self-motivated and results-oriented, yet flexible.
- Medical knowledge of infectious blood-borne diseases is a plus.
- Experience in the pharmaceutical area is a plus.
- Fluency in English and at least in one national language.
- Good knowledge of MS-Office.
**Our Company**
- Prothya Biosolutions makes life-saving plasma medicines and is proud of that Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn
**We offer**
Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.
We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding.
Furthermore, we value mutual respect and diversity is our strength.
For each Prothya Biosolutions Belgium employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.
**Do you move with us?** Then
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