Coordinator Training

**Job description**

**Role**: Training Coordinator Quality

Reporting to the Supervisor QA Systems & Compliance,

**Objectives**:
As Training Coordinator Quality working dotted line with the Lead QA Training, you are responsible for leading the training organization from a QA perspective (i.e. mainly GMP trainings) for the entire Prothya Biosolutions Belgium organisation. 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 Training Coordinator within the QA department, you are responsible for the Training administration within the Department and provide assistance to the whole QA department on topics related to trainings (trainings plans, training strategies, etc.). You are also part of the training coordinators network and as such assist each other’s as needed to set-up and maintain the trainings system.

**Key responsibilities and result areas**:
You contribute to the general Prothya training structure:

- You provide input to set up the Prothya general training policy ;
- You ensure declinaison of the Prothya Training Policy into standard procedures and their implementation;
- You ensure that the Prothya training policy is in line with prevailing EU and FDA GMP guidelines;
- You provide the required templates so that the training programme can be implemented uniformly within all GMP-related departments;
- You hold a periodic training review meeting with all training stakeholders (Global Training lead, Training Coord., Managers, etc.) ;
- You support the other departments, where necessary, in implementing the general training policy;
- You act as an Expert during various customer audits and inspections by authorities.

You are responsible for GMP-related training courses that are the QA’s responsibility.
- You draw up the annual schedule for the GMP training courses and ensure that these are correctly implemented;
- You are responsible for organising, developing, and implementing the GMP introductory training courses, more intensive GMP training courses, GDP training courses, Data Integrity training courses, Inspection Readiness training courses, etc.

You manage the Training Quality Assurance Department.
- You ensure the administration of the training system for the QA department (register trainings in training database, you manage the documentation related to it, etc)
- You draw up Training Plans for all QA employees;
- You draw up qualification forms for the critical tasks within the QA Department;
- You follow up on the Training performance within the QA Department;
- You guide the QA Supervisors on the who and how of the training programme, in accordance with the GMP guidelines, with the goal of meeting the training needs of their employees.

You provide Training support to other Prothya departments:

- You provide support to other Prothya departments in drawing up their training plans, qualification matrix, and qualification forms;
**Profile**:

- You have a Master degree or equivalent by experience
- You have min 3-5 years of experience within a similar role (pharmaceutical sector is an advantage);
- You are familiar with working in a regulated environment, American and European GMP guidelines (Good Manufacturing Practices);
- You are fluent in Dutch and French; a good knowledge of English is an asset;
- You like and have experience in giving trainings;
- You have experience in setting up and/or dealing with a training system within a same-sized company;
- You take initiatives and are decisive;
- You are autonomous and can manage/work independently;
- You have experience working with multiple internal stakeholders;
- You are persuasive, communicative, team player and can defend a point of view;
- You have a pragmatic spirit, you can easily multitask, 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, Su