Our client is a global pharmaceutical company that specializes in developing and producing innovative medicines and vaccines. They currently operate across 140 different countries in several therapeutic areas.
As a Senior Qualified Person in the Quality Release department, your responsibilities include temporary release of packaged medicines, initiating and implementing quality improvements, providing advice on technical and compliance issues, and implementing solutions. You report to the Associate Director Quality Release Blister.
- Participate in the Contract Management Organization (CMO) project, representing the Quality department and dealing with its complexities and significant impact
- Perform batch release duties as a Qualified Person and maintain communication with colleagues from Organon
- Address batch-related inquiries from Organon’s Qualified Persons and provide explanations regarding processes and decisions when necessary
- Quickly familiarize yourself with the current process and contribute to the design of future processes, considering their organizational impact
- Offer support to colleagues dealing with intricate issues
- Ensure compliance with regulations and adhere to established lead times for Operational internal CoE Quality activities
- 5+ years’ experience within a QA / QR position
- You are a registered Qualified Person
- Completed QO/ MSc education in a related field
- Experience with the batch releases
- Excellent communication skills and a team player
- Fluent in both Dutch and English
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.