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Senior Assistant Product Support
Il y a 4 mois
Function Senior Assistant Product Support - Joblevel 7**Report to the Supervisor Product Support "Process and Validation"
Responsibilities
- Creation and update of Master batch records and maintenance
- Creation and update of specifications
- Creation and handling of Change controls
- In addition, all activities related to GMP obligations once process methods are in routine manufacturing
- management of raw materials and intermediates specifications
- Concurrent Qualifications
- All activities with aim to transfer new technology at Prothya Biosolutions for routine manufacturing activities including all validations and documentations for authorities file registration.
- Willing to participate in the continuous improvement within projects
Profile
- Relevant Bachelor degree (e.g. Engineering, Biochemistry, Pharmacy)
- You are entrepreneurial and operate comfortably in new business environments and can work independently by taking ownership.
- Minimum of 3 years' experience in writing documents such as work instruction, SOPs, Batch records, etcFamiliar with process validation in a pharmaceutical industries environment.
- Experience with quality management system elements like deviations, Change Control, CAPA's, Change Notifications, Quality agreements, etc
- You are analytical, good at solving problems and have excellent verbal & documentation skills.
- You are resultoriented and decisive and can balance quality & business aspects
- You are fluent in English, Dutch and/or French.
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? 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.Furthermore, we value mutual respect and diversity is our strength.
For each Prothya Biosolutions Belgium employee, from operators to the CEO, engagement means showing initiative.
We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.
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