Coordinator QA Systems – Internal Oversight | Brussels
Job title : Coordinator – QA – Internal Oversight
Prothya Job grade : 8
Reports to : Supervisor Global QA Systems
Unit & Department: Quality / Quality Systems Global
Purpose of the job:
As part of your role, you will be responsible for proactively managing the eQMS requests, SAP code requests and QA training (internal oversight).
Key activity
1. Internal Oversight :
- Performing duties related to QA Systems Superuser eQMS, Audit Module, access management, eLMS and maintaining the MC system including Email inbox management.
- QA training coordinator , Registration of the QA given trainings, creation Training plans for QA, training review in Master Control to determine QA group R&U, create/retire QA R&U codes, keep up-to-date R&U job-codes for QA, including consultants and temporary employees. R&U JML( Joiner, Mover, Leaver), Email inbox management.
- Responsible for training on GMP, Data Integrity, GDocP, train the trainer and onboarding GMP intro.
- SAP code request management from a QA point of view
Reporting
Internal Oversight:
- Follow up and report on metric related to the eQMS mailbox.
- Follow up on training metrics for the QA department in Belgium
Leadership
- Ensures a safe, secure, and healthy work environment.
- Ensures collaboration within the team and other departments
Stakeholder Management
Internal Oversight:
- Interact with all departments related to eQMS questions
- Interact with all departments related to GMP trainings
- Be the point of contact for QA training issues for both QA systems in Belgium and QA operational.
GxP
Has understanding of existing regulatory GxP requirements (within area of own expertise). Interacts cross functionally to ensure GxP compliance and writes SOPs. Follows mandatory GxP training and maintains an appropriate training record. Writes GxP documentation such change control records.
Education level
- Master in (bio)chemistry, process technology, or pharmacy.
Work experience
A minimum of 5 years experience in the pharmaceutical industry , preferably in a quality or regulatory department.
Skills
- You are able to work independently and have a customer-oriented approach.
- You are stress-resistant and results-oriented.
- You have a good knowledge of MS Office.
- You have good presentation skills and the ability to train other employees
- You are fluent in spoken and written English; you are fluent in French and Dutch.
- You have a general quality mindset
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 and homeworking after a successful onboarding (after 3 months).
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!
Are you moving along? Then apply now!