As an Administrative Assistant within the Quality Control (QC) Department, you are responsible for providing administrative support to the QC team. You ensure the execution of both specific and general administrative tasks within the department.

Accountabilities

1. Execution of Specific Administrative Tasks within the Department

Administrative Support

Provide support for the activities and responsibilities of the QC Administrative Assistant.

SOPs and Documentation

Ensure that documents and procedures are prepared according to the required format and layout.
Initiate the workflow of procedural documents within the Electronic Document Management System (EDMS) and manage their approval and release in the system.

Data Review

Review analytical results and associated documentation, including raw data and audit trails.
Analyze and assess results against established specifications and acceptance limits.
Archive worklists.
Perform daily follow-up of worklists in collaboration with the QC Improvement and Release Team.

Training Administration

Register training documents in the training management system.
Deliver training related to basic QC administrative tasks (for example, access training for Quality Control areas).
Maintain and update the competency matrix by recording training data and the date of the latest completed assessment.

2. Communication with the Operational Team

Provide constructive feedback when deviations or discrepancies are identified during reviews.
Ensure follow-up of comments and open action items through the designated tracking system.

3. Support to the Senior Quality Technician QC in Quality Record Reporting (Events, OOX, CAPAs, MOCs)

Collect the necessary supporting documentation (worklists, reference documents, protocols, etc.).
Link and upload the relevant documents into MasterControl.

4. Continuous Improvement and Performance Monitoring

Support continuous improvement projects within the QC department.
Report on assigned KPIs using existing or newly developed reporting tools.

5. Stakeholder Management

Key stakeholders include:

QC Improvement and Release Team
QC Lab Support Team
QC EM/Utilities Team
QC Operations Team
QA Operations
QA Systems

Education, Experience and Skills

Education

Bachelor’s degree, preferably in Office Management, Administrative Support, Secretariat Studies, Translation, or a related field.

Work Experience

Initial relevant experience in a similar administrative position or equivalent role.
Knowledge of the pharmaceutical industry and QC laboratory environment is required.

Skills

Basic proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
Fluent in Dutch or French, with a good command of English, both written and spoken.
Knowledge of quality systems, GMP (Good Manufacturing Practices) guidelines in accordance with European and U.S. regulations, and SOPs (Standard Operating Procedures) is an asset.
Strong team player with excellent communication skills.
Ability to process information accurately and work with a high level of precision.
Flexible and comfortable performing routine administrative tasks.
Knowledge of SAP.
Organized and detail-oriented with a structured approach to work.
Able to manage recurring administrative tasks efficiently and effectively.

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? At 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.

Furthermore, we value mutual respect and diversity is our strength.

At 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!

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