Internal Oversight Senior Coordinator QA systems | Brussels or Amsterdam
Job Title: Senior Coordinator QA systems internal oversight
Reports to: QA Systems Supervisor Internal Oversight
Delegation: Tasks can be delegated to designated personnel in their absence.
Unit & Department: QA Systems Internal Oversight
Location: Nederland or Belgium
Purpose of the Job: As a Superuser for eQMS, you will maintain the integrity of the MasterControl (MC) system.
Main Responsibilities & Accountabilities
Key Activities:
- Perform duties related to the eQMS and Audit modules of MasterControl.
- Handle access management, including the Joiner-Mover-Leaver process, and register trainings given by QA personnel. Request changes to user accounts using IT tickets.
- Resolve eQMS and Audit forms and functionality-related issues raised by end-users, including managing the Superuser mailbox which functions as a helpdesk for MC.
- Create or support the creation of trainings and training plans. Manage the FAQ related to eQMS and Audit. Act as a trainer or back-up trainer if qualified based on expert knowledge.
- Maintain and enhance existing or develop new Management Control (MC) reports for the Electronic Quality Management System (eQMS) and Audit forms, ensuring accuracy and relevance. Be a process owner of the A&R process, including providing classroom training on this process. Deliver technical data for the Power BI reporting tool to IT.
- Oversee the operational aspects of the MC system, ensuring smooth functioning, and take actions related to security and data integrity to uphold system integrity.
- Lead efforts for continuous improvement and optimization of eQMS and Audit forms, enhancing functionality and usability to streamline quality management processes. Provide support for implementing changes to the MC system.
- Serve as an intermediary between key-users (SMEs of QMS processes) or end-users and the IT department or system administrators. Submit IT tickets or MC tickets when needed for issues or enhancements. Facilitate communication and support between users and system administrators.
- Actively spread knowledge concerning the MC system. Act as chair of meetings concerning eQMS subjects with key-users.
- Act as back-up for the QA Systems Superuser eDMS.
Requirements:
- Experience: A minimum of 5 years in quality assurance within the pharmaceutical sector, ideally with experience in quality systems.
- Skills: Excellent communication, stakeholder management, and problem-solving abilities, with the drive to implement and manage system improvements. Experience to work in a GMP environment.
- Education: Bachelor’s degree in life sciences, quality management, or a related field.
- Languages: Fluent in English. Dutch or French proficiency is beneficial.
- Technical Knowledge: Familiarity with MasterControl or equivalent quality systems software is highly advantageous.
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!