Qualified Person and Quality Assurance Manager
Il y a 5 mois
**WHO ARE WE?**:
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Now, we are powered by 53,000 employees globally who nurture a diverse, collaborative, and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
ROPU MIDI is a Regional Operating Unit consisting of 8 mid-sized countries: Belgium, Denmark, Norway, Finland, Greece, Portugal, Sweden, and The Netherlands. MIDI is a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.
***THE OPPORTUNITY - DO WORK THAT MATTERS**:
We are seeking a highly motivated Qualified Person (QP) professional with GMP expertise to join us as the new QP - Quality Assurance Manager at Boehringer Ingelheim Veterinary Medicine Belgium (BIVMB). At BIVMB we focus on the equine mesenchymal stem cells platform, addressing the unmet needs of multiple veterinary patients.
In this exciting role, you will be responsible for daily management and operation of the quality management system. You will execute the regulatory role as QP and certify the release of batches to the market. You will be working with state-of-the-art technologies.
This position is based in Evergem, Belgium, and reports directly to the Head of Quality.
Please be informed interviews will take place after May 30th.
***FURTHER KEY RESPONSIBILITIES**:
- Promote quality achievement and performance improvement throughout the organization and train the personnel.
- Detect and analyze the needs concerning quality within the business unit and initiate projects to improve the quality in an efficient and effective way.
- Write and maintain procedures, work instructions and instructions for maintenance and calibration.
- Ensure correct handling of OOS/OOT, deviations, complaints, CAPA's and changes in the relevant scope, with their associated actions Ensure compliance with national and international standards and legislation.
- Organize and perform internal audits throughout the entire production process and report its results to guarantee the quality of the product.
- Perform external audits for qualification of suppliers and subcontractors.
- Organize and check the maintenance and qualification of premises and equipment.
- Quality Review of quality documentation, process records, batch records and labels.
- Aid in continuous improvement of the Quality System.
- Ensure that quality documentation from and for suppliers comply with BIVMB requirements.
***WHAT YOU SHOULD BRING TO THE TEAM**:
- At least 3 years of experience as an authorized Qualified Person for aseptic pharma products.
- Master’s degree in Life Sciences, Veterinary Medicine or similar.
- Profound knowledge and training of Good Manufacturing Practices.
- Excellent command of the English language. Dutch is a plus
- Excellent communication skills.
- Flair for electronic data handling and reporting. Strong skills in documentation, detail-oriented, analytic, administrative Quality-conscious, well-organized, and attentive to detail.
**YOUR BENEFITS**:
- Work in a wellbeing-oriented organization (Premium access to Headspace and ongoing support and initiatives related to ways of working to help our employees to stay healthy and constantly improve the physical, emotional, mental, and spiritual well-being).
- Customized Development plan based on your role and aspirations, with several learning platforms such as LinkedIn Learning Premium, and access to international development opportunities and languages + training programs.
- Good balance between work and free time (Mix of working from home within the respective country / office as well as flexible working hours).
- Working in a passionate team within a fun, diverse, and multicultural working environment.
- Full time basis with 20 legal holidays and 12 time reduction days. Competitive salary package and extralegal benefits.
**What’s next?**:
We will have a look at your CV and cover letter. If we see a match, we will invite you for a video call interview to get to know each other. Are we still positive? We might schedule a second interview and possibly a small Business Case. We will keep you posted during the process
**DIVERSITY & INCLUSION**:
At Boehringer Ingelheim we share the opinion that diversity and inclusion is essential for the growth of our business and that our strengths and competitive advantage are also the result of the diversity of our company - diversity across the three dimensions of inclusion: Gender, Geography and Generation. Our people are part of a deep-rooted, family company philosophy that welcomes everyone We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for al
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