QA Officer

il y a 3 semaines

Brussels, Belgique STADA Arzneimittel AG Temps plein

**About EG**
- EG is a Purpose driven company: at the core of everything we do, we aim to Care for People´s Health as a Trusted Partner.- EG is the largest pharmaceutical company in Belgium.- With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.- Most of our medicines and food supplements are produced in Belgium. We currently have 180 employees and continue to invest in:
- The development of generic medicines to keep qualitative healthcare affordable
- Scientifically proven food supplements and medical devices that you can buy without a prescription in your pharmacy
- The development of highly specialized medicines and biosimilars
- Our culture is characterized by the strong commitment of our employees. Internally, we are called “MEP’s”: Motivation - Energy - Passion are therefore qualities that we look for in every potential new employee to help strengthen our culture.- We are part of the Stada Group and share the values Integrity, Agility, Entrepreneurship and One Stada.- Do you have a strong MEP level? Are you entrepreneurial and would you like to work for the largest and fast-growing pharmaceutical company in Belgium? Then EG might be the perfect employer for you.**About the department Pharmaceutical Afairs**
- Pharmaceutical Affairs (PA) Department consists of Regulatory Affairs, Quality Assurance, Medical Affairs and Pharmacovigilance. The department ensures that our products are produced and delivered to customers according to the highest quality and safety standards and complying with the local and EU regulatory requirements.**About your role**
- The Quality Assurance Officer (QAO) supports the maintenance and continuous improvements in the Quality Management System (QMS) to ensure quality operations and processes are in full compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP) and local regulatory requirements.- The QAO will collaborate with internal departments (Supply Chain, Controlling,) and external partners (external warehouse, CMO’s,) to ensure a smooth launch and continuity of the products on the market.- This role is part of a team of 2 Officers and 1 Specialist and reports to the Quality Assurance Manager.**Responsibilities**
- Release of medicinal products for distribution to the Belgian and Luxembourgian market
- Review and alignment of Quality Technical Agreements with suppliers
- Performing of internal and external GDP audits
- Support of launches and transfers of (new) products
- Write and assess of deviations and/or non-conformances
- Handling of product customer complaints
- Review of Product Quality Reviews
- Support of product recall process
- Revision and maintenance of Standard Operating Procedures
- Preparation and revision of vendor qualification documents
- Preparation and revision of customer qualifications documents
- Assist in regulatory inspections (preparation and follow-up)
- Initiate and assure follow up on CAPAs (Corrective Action Preventive Action)
- Review of ongoing stability studies results

**Required profile**
- Motivated, Energetic and Passionate (MEP)
- You act in line with our values: Integrity, Entrepreneurship, Agility and One Stada.
- Degree of Bachelor, Higher education or Master in a scientific or (bio-)medical education (e.g. Pharmaceutical Sciences/Pharmacist, Bio-medical sciences, Drug Development or equivalent)
- Relevant work experience: 0-4 years
- You're open-minded, collaborative, team player, ready to adapt to the changing needs
- You’re curious about new techniques and tools, and eager to always keep learning
- You have good organizational and planning skills
- Knowledge of pharmaceutical terminology is a plus
- Fluent in Dutch, French, English
- We hire for attitude

**What you can expect from EG**
- Your efforts will be rewarded with an attractive and competitive salary.
- On top of this you will receive a full package of fringe benefits such as meal and eco vouchers, group insurance, ambulatory care and hospitalization coverage, laptop & smartphone So, you go through life without any worries
- We offer a company car including a fuel card for some functions. Functions that don't include a company car, can be part of a cafeteria plan where you give part of your gross salary for a car and fuel card.
- Do you prefer to get some fresh air every morning and evening? Great Because bicycle leasing is also possible as part of our cafeteria plan.
- You also get to enjoy a very nice work-life balance with 32 vacation days and a flexible work schedule. Working from home for two days a week is also possible.
- Finally, you can count on a big smile from your new colleagues every day We all work towards one common goal: Caring for People's Health as a Trusted Partner, with the same Motivation, Energy and Passion across all departments. You will have regular the possibility to connect with all our Belgian colle

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