Function: Coordinator global QA systems
Reporting to the Sr Supervisor Global QA Systems
Purpose:
As Coordinator global QA Systems
Accountabilities
As Coordinator global QA systems you will be part of the Global team internal oversight. The team consisting of colleagues in Belgium and The Netherlands is responsible for quality risk management, quality management review, documentation and record management, the compliance board and the training system. The team members are SuperUsers of the electronic signature system, electronic Documentation Management System, electronic Quality Management System and the Learning Management system.
Currently we are specifically looking for two colleagues with preferably experience in one or more of the following topics:
- SuperUser eDMS including retrieving metric from the system
- QA Training coordinator and GXP trainer
- Quality risk management
- Archiving
As training coordinator you ensure in coordination with the Global Lead Training that the training system in place is compliant to GMP requirements and aligned to the organization needs. You ensure that the training process is implemented uniformly and coordinated for the entire organisation, as well as making sure that all departments comply with general training procedures. You are also responsible for providing GMP-related training courses that are the responsibility of the Quality Assurance organisation, e.g. GMP training courses, Data Integrity training courses, Good Documentation Practices, etc.). You also provide support in terms of training programmes within all other Prothya departments.
As SuperUser eQMS you ensure user management together with IT. You are constantly searching for ways to inprove the system towards a better user experience and optimal compliance. Next to that you provide metrics to the organization and facilitate the monthly Quality Management Review meetings. You will also be involved in implementing the eQMS system at Prothya Hungary.
As Quality Risk Management Coordinator you are responsible for the maintenance of the (compliance) risk register. You will support the Sr supervisor with preparing the compliance board and will be responsible for Regulatory Surveillance.
All team members of global QA Systems support regulatory inspections and customer audits as part of the back office. Conducting internal audits and blood bank audits could also be part of the role.
Profile:
- Bachelor’s degree in Chemistry, Pharmacy, Biology or related.
- You have min 3-5 years of experience within a similar role (Quality experience is a must, pharmaceutical sector is an advantage);
- You are familiar with working in a regulated environment;
- You are fluent in English writing and oral skills;
- You preferably also have knowledge of Dutch and/or French;
- You have excellent communication skills;
- You have experience in the subjects as mentioned above;
- You have a pragmatic spirit and you are solutions and quality oriented.
- You are comfortable working and dealing with IT tools.
Our Company
Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions' mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya's slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people.
We offer
Prothya Biosolutions BE 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 BE offers once a year.
We also offer an attractive holiday system exceeding the legal holidays.
Furthermore, we value mutual respect and diversity is our strength.
For each Prothya Biosolutions BE 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.
Are you interested? Send your CV and covering letter.
