As a Senior QA Systems Officer at Delpharm Development Leiden, you will play an important role in overseeing the development, implementation, and maintenance of our Quality Management Systems (QMS). You will ensure adherence to regulatory standards and internal policies, leading critical processes such as deviation management, change control and risk assessment.
May 24, 2024
Sr. QA Systems Officer
Delpharm Development Leiden is a dedicated development center within the Delpharm network, focusing on injectable dosage forms. Connecting our team of experts with advanced equipment, like our recently acquired HRMS, we position ourselves as specialists in our field. Providing a comprehensive range of services from research & development to clinical phase. Our team, capable of handing potent compounds, sets high standards when it comes to safety, quality and employee well-being. Driven by the aspiration to continuously enhance our services, we apply methodologies such as Quality by Design (QbD), data science and lean principles. These practices not only contribute to the refinement of our internal processes but also enable us to meet the evolving needs of our customers with the end goal in mind: impacting the patients life.
Delpharm Development Leiden B.V
Responsibilities
- Oversee the development, implementation, and maintenance of quality management systems (QMS) to ensure adherence to regulatory standards and internal policies.
- Lead the development, implementation and maintenance of QA systems, including deviation management, change control and risk assessment processes
- Manage supplier oversight activities, including reviewing Quality Agreements, generation of yearly Audit Plans and maintaining approved supplier list.
- Conduct regular reviews and updates of quality system documentation to reflect process changes, ensuring accuracy and compliance with regulatory requirements.
- Support in the planning and execution of internal and external audits, ensuring readiness and compliance with audit requirements.
- Serve as a subject matter expert on quality systems, providing guidance and training to employees on quality procedures and documentation requirements.
- Collaborate with cross-functional teams to identify areas for process improvement, streamline quality systems, and drive continuous improvement initiatives.
- Monitor key performance metrics related to quality systems and prepare reports to communicate trends, areas of improvement, and compliance status.
- Assist in the preparation and submission of regulatory filings and documentation as necessary.
Profile
- Bachelors’ degree in a scientific discipline or relevant field
- 5+ years of relevant work experience
- Proficiency in document management and software applications (QMS)
- Experience in regulatory/customer audits preferred
Offer
- A great place to work within a team of motivated specialist
- Learning and development opportunities
- Market conform salary based on experience (65K-75K annual)
- Variable pay bonus
- 25 holidays + 6 Delpharm designated days
- Pension scheme including personal options such as partner pension, ANW shortfall and extra savings
- NS business card or Travel allowance
- Laptop
Other information
Furthermore, joining Delpharm Leiden means becoming a member of an international and diverse organization. We have a close team fostering lasting connections, where many individuals have dedicated 10 years or more to our collective success. Together with our active Staff Association we arrange several social activities a year and share work, hobbies and personal experiences in our frequent get togethers and our staff magazine. These and many other initiatives allow us to create a rich and supportive community within our workplace.
Want to become a Sr. QA Systems Officer at Delpharm Development Leiden? Apply via: https://jobs.jobvite.com/delpharm-leiden/jobs
Questions?
Our HR department is available by phone, mail or WhatsApp.
Phone: 071 524 4044
Email: job.leiden@delpharm.com
App: 06 2322 9835
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Please note that we prioritize local hiring and, as required by Dutch law, will be conducting an initial search within the local talent pool. Therefore, we kindly request that only applicants residing locally apply at this stage. Applications from candidates residing abroad will not be processed during this phase. Thank you for your understanding
