Position: Senior Quality Engineer QA OPERATIONAL
Reports to the Manager QA BE


Objectives:
As Senior Quality Engineer, you are responsible for guaranteeing quality by following up and ensuring that all operations at all levels are done according to the applied Gx P quality systems at Prothya Biosolutions BE. In this way, you help ensure that the quality of the pharmaceutical products from Prothya Biosolutions BE fulfils the European and American GMP guidelines.

Key responsibilities and result areas:
1. You are responsible for guaranteeing quality by following up and ensuring that processes and activities are carried out according to the applicable c Gx P quality standards such as:

• You assess events/deviations, OOS/OOL and complaints (to vendor);
• You monitor written documents such as procedures, protocols and reports concerning quality systems from other departments;
• You take care of the correction and authorization of those procedures, protocols and reports;
• You perform Gx P-checks on the shopfloor in different departments and support people to improve;
• You assist in the preparation of audits and act as a contact person during inspections;
• You coordinate daily all activities related to release of batches;

2. You participate in different projects related to risk analyses, qualification and validation:

• You are responsible for performing risk analyses and determining corrective and preventive measures (CAPAs);
• You monitor changes via Change control;
• You are the QA contact person for operational change controls;
• You participate in or supervise quality-related projects;

3. You are responsible for informing, making aware and training Prothya Biosolutions BE employees:

• You contribute to guaranteeing the quality level and you work on continuous (quality) improvement;
• You are responsible for informing colleagues about quality, pharmaceutical legislation and rules;
• You are responsible for encouraging employees to respect the pharmaceutical rules;
• You follow up on the training of new employees and report training progress to the supervisor/manager;

4. You support in the development and implementation of metrics in the QA operational department.

• You escalate metrics at risk to the manager;
• You are responsible for the organisation of the quarterly QMR meetings within Prothya and with clients;
• You are the back-up of the manager in reporting these metrics to management;

5. You are the responsible for the communication between the QA department and clients.
Profile:

• You have a Master’s degree (preferably in Chemistry, Industrial Pharmacy, Biotechnology, etc.) or equivalent through experience;
• You have at least 6 to 10 years of experience in a similar position in the pharmaceutical, medical device or biotech sector;
• Knowledge of quality systems is a requirement; experience with European and American GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is a bonus;
• You work efficiently with MS Office package; knowledge of SAP/ Master Control is an asset;
• You can communicate fluently in English (both spoken and written), and you have a good knowledge of Dutch and/or French;
• You are analytical and good at solving problems;
• You are result-oriented and decisive; You can set correct priorities
• You are customer-oriented, persuasive, communicative, and cooperative;
• You are stress-resistant.

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!


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