QA Professional for Packaging Development

Are you motivated to serve as the ambassador for millions of patients worldwide, safeguarding their safety? Are you a solution-oriented individual with a strong passion for Quality Assurance? Do you find inspiration in actively utilizing quality as a driving force when integrating medical device and pharmaceutical development projects, particularly in primary packaging? If yes, then you might be the ideal fit for our Devices & Delivery Solutions Quality team in Hillerød, Denmark. Apply now for our Quality Assurance Professional position! The position As a Quality Assurance Professional, you will play a significant role in a rapidly growing QA development area, contributing to both existing and upcoming projects, supporting them in implementing suitable quality strategies and reviewing and endorsing design control documents. Your involvement will encompass navigating medical device and pharmaceutical regulations throughout the entire primary packaging development process, guiding it from inception to product launch by contributing to project planning and ensuring successful milestone delivery at each stage. You will collaborate with a diverse range of stakeholders at [xxxxx] and external development partners, you will be responsible for setting the direction for quality in line with both internal and external requirements. Your key responsibilities will include effectively balancing quality with other project objectives and providing clear direction. Core responsibilities include:

Providing quality oversight of the primary packaging development process.

Reviewing and approving development documentation regulated by GxP requirements.

Handling most situations independently, applying your subject matter knowledge to identify best practices and drive improvements to Quality Assurance processes.

Playing an active role in sharing knowledge and learnings to empower your colleagues.

Providing active assistance during authority inspections and internal audits, both in the practical setup and in supporting the projects in presenting documentation.

Qualifications To fulfill this role, you have:

A degree in pharmaceuticals, chemistry, engineering, or a relevant field with a strong emphasis on quality.

Substantial experience in the pharmaceutical industry.

A proven track record in interpreting regulatory requirements, ideally well-versed in standards such as: EU GMP - part I, II, III, and IV, 21 CFR 210/211/820; 21 CFR part 4; Ph Eur, USP.

Proficiency in written and spoken English at a professional level.

Experience in actively participating in audits and leading them is advantageous.

Furthermore, you actively and constructively engage stakeholders and can navigate cross-organizational landscapes. Your ability to swiftly comprehend situations and dilemmas, combined with a solution-oriented approach to introducing innovation within procedural and regulatory frame, is a strength. You also possess the skill to translate regulatory guidance into operational practice, furthering the development of devices. Clear communication and the ability to present your perspective using factual information when necessary to ensure regulatory compliance or patient safety is crucial. Your keen eye for process improvement, coupled with the drive to effect change, is highly valued. About the department
Devices & Delivery Solutions Quality is accountable for covering all quality aspects in the development portfolio of primary packaging, mechanical devices, devices with embedded electronics and software, and software as a medical device, as well as projects investigating new paradigms for drug delivery. Further, we work on Quality Management System activities, quality oversight of our suppliers, and host inspections.

We are an international team of 38 passionate Quality Assurance experts with diverse backgrounds of which the vast majority is based in Hillerød, Denmark - and a small part is located in USA. Along with the rest of the device development area, we have a high focus on patients and take pride in having a significant impact on the life of patients by ensuring high quality, safe, and effective products. Working at [xxxxx]
At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information please contact Dean Kloe at [xxxxx] . Deadline
23 June 2024. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.