Quality Specialist, EU Commercial Product Quality
Vor 3 Tagen
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The incumbent will report into the Senior Manager EU Commercial Product Quality Team Lead. The incumbent will be responsible for supporting activities relating to BeiGene’s external GxP operations as well as internal BeiGene GxP processes, ensuring procedures and systems are followed to support BeiGene’s commercial activities.
The position is based in Europe.
Essential Functions of the job:
Follow internal Standards to support batch review and release Collaborate with Contract Manufacturers to support batch review and release Collaborate with other functions to facilitate batch release Supporting Quality reviews of documents and assist with issue resolution Schedule, track, and assist with running of meetings; create meeting summaries Being responsible for Deviations and Change Controls Perform other duties as assigned within External Supply Quality as applicableExperience:
More than 5 years pharmaceutical or biotechnology industry experience. In-depth GMP experience in a quality and manufacturing function.Core Knowledge and Skill Requirements :
Knowledge of GMPs/GDPs, especially focus on GMPs. Knowledge of Quality principles, concepts, industry practices and standards. Working Knowledge and experience with EudraLex EU GMP Guidance, 21CFR210, 21CFR211, ICHQ7 as well as international regulations. Follow internal Global Standard to support temperature excursion handling Excellent verbal, written and interpersonal communication skills. Ability to work independently with scientific/technical personnel. Experience with regulatory compliance inspections. Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Must possess strong presentation skills to speak effectively before groups; ability to respond. Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail. Experienced with working cross-regions with Clinical, Supply Chain, Regulatory, and Development departments Spoken/Written fluency in English required Spoken/Written fluency in German/French/Italian preferredComputer Skills:
PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio) Veeva Vault Quality Docs; Veeva Vault Quality Suite; Veeva Submissions; SAP; IWRS; Audit Utopia; Empower; LIMS, etc. UL ComplianceWire; UL LearnShareTravel:
May travel approximately 10%BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity-
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