Quality Control Specialist Experienced in Glass Primary Packaging

Job title:

Quality Control Specialist Experienced in Glass Primary Packaging

Company:

Fujifilm

Job description

We are looking for a strong scientist with experience in raw materials and primary packaging for drug product manufacturing. We are looking for a structured, pragmatic and diplomatic person that can support the drug product area within Global QC Raw Materials Tech Transfer.You will be accountable for ensuring operational readiness of the drug product facility in relation to raw material topics. Additionally, you will be responsible for collaborating internally with the raw material team and externally with our customers to define, evolve and determine the testing strategy for primary packaging, materials and utilities used in the drug product facility.Additionally, you will be involved in tech transfers for new customers and be a key stakeholder in ensuring method capabilities both internally and externally for the primary packaging components.Primary tasksRepresenting Global QC Raw Materials in the Operational Readiness project, ensuring the facility and the processes implemented are compliant with regulations and work in an operational setup.Defining and building out the testing strategy for primary packaging.Determining the testing strategy together with our customers for the individual programs depending on the customers needs.Maintaining knowledge on regulatory guidelines, general chapters etc. That are relevant to the primary packaging area (e.g. Annex I)Ensuring method onboarding both internally and externally to facilitate incoming control of primary packaging.Actively engaging with customers and internal stakeholders to ensure tech transfer readiness per manufacturing schedule.Authoring specification justifications and corresponding specifications for primary packaging materials, disposables and raw materials used in the DP manufacturing processes and any devices to be used together with the productFocus on continuous improvements to all our processes and challenge status quoQualificationsMaster’s degree (MSc) within e.g. Chemical Engineering, Biochemistry, Biotechnology, Pharmacy or equivalentStrong knowledge and understanding of regulatory guidelines and technical areas related to primary packaging, materials and utilities for drug products.Proven GMP experience from similar pharma companies.Solid experience from a similar role (preferred)Good communication skills in EnglishGood collaboration skills in a very dynamic environmentPersonal qualificationsAs a person you have a positive can-do attitude, you are proactive, pragmatic and can move easily between tasks. You are organized, work efficiently and can structure your tasks in a way to ensure projects are completed on time – even when the priorities change. You have good communication skills and can communicate well and clearly with both internal and external stakeholders. You take responsibility for your tasks and ensure escalation to the project team and management when needed. You are self-motivating and always willing to give a helping hand to other team members when needed – and you thrive in a busy environment.Who are we?You will be part of the Global QC Raw Material Department. The department manages materials and methods for our customers in connection with new product introduction for both drug substance and drug product manufacturing.About FUJIFILM Diosynth Biotechnologies and our Quality department (QC)FUJIFILM Diosynth Biotechnologies is a world leading contract manufacturer of biological medicine (CDMO), with the latest investments in Hillerød we will become the largest end-to-end CDMO site in Europe. We service global customers in the medical industry – from pre-clinical to full commercial GMP production. Our mission is “Advancing Tomorrow’s Medicines” supplying patients with important medicines and we would like to invite you on the journey.Our quality department (QC) in Hillerød consists of more than 200 employees divided into several analytical and support functions. We strive to have a strong QC-team spirit (OneQC) where we can support and cooperate across functions and teams – not solely for reaching goals but also to strengthen personal development. The foundation in our QC-departments is our employees and our success is only possible due to our competent and dedicated colleagues that work to make a difference for QC, our production facility, customers, and patients all over the world.As an invaluable part of a leading CDMO, QC strives to continuously improve our processes and analytical methods while creating a dynamic and inspiring environment where there are great possibilities to be part of changes and drive improvements.What can we offer (#BestPlaceToWork)If this is you, we can offer an exciting and challenging position in a company in growth with many new customers and products in the pipeline. Also, you will be part of an organization and team of competent and engaged coworkers.The culture at FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is the most important if you ask our employees. We offer:An exciting journey on a fast-growing commercial pharma site with lots of development opportunitiesAn attractive salary package including health insurance, health check, fitness center and moreDedicated colleagues, a great team and department culture, and inspiring site spiritApplicationIf this could be your future position, please upload your application and CV. We will review relevant candidates for job interviews and will close the position as soon as we have found the right candidate.If you have further questions or need information, please contact Associate Director, Patricia Jacobsen by emailFUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Wed, 05 Mar 2025 03:11:17 GMT

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