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Product Quality Associate, IMP
Il y a 3 mois
To further strengthen our Quality team, we are looking for an experienced and motivated Product Quality Associate, IMP. The Product Quality Associate, IMP will play a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams and will be responsible to ensure the quality oversight of CMO's involved in secondary packaging and labeling of IMP batches, and to follow-up on the timely completion of the Batch Record Review of IMP batches.
Reports to:
Head Development Product Quality
Key Accountabilities and Responsibilities:
In close collaboration with external and internal manufacturing and supply teams from both CMO and the company conduct or supervision of quality assurance activities regarding, but not limited to :Review of executed batch record documentation of IMP batches and support release of IMP for clinical studies ensuring timelines are metReview of deviation investigations related to manufactured batches and related corrective and preventive actionsReview of change control related to manufacturing processes and related effectiveness checksReview and support assessment of temperature excursionsSupport in compiling of submission dossiers for Clinical Trial ApplicationsProvide strategic GMP guidance to third-party vendors and partners to ensure quality and compliance of argenx products.Review of Product Quality ComplaintsSupport Mock recallMonitoring of the performance of the manufacturing and distribution processes through metricsReview quality agreements with external parties.Contributes to internal and external audit planning and follow-up and support the Global External Audit Program through the execution of qualification audits and routine GMP audits of argenx supply chain; Support HA inspection and work with internal stakeholders and external parties to prepare for these inspections.Support follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementationSupport the further build-out of quality processes and systems.The role may also support the QA team with additional ad hoc project supportDesired Skills and Experiences:
5y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in biological manufacturing operations.Experience with Batch Record Review is a plus.Experience with working in an outsourced model, closely collaborating with a CMO is and asset.Experience with audits and experience with preparation of regulatory inspections (FDA, EMA, PMDA, ... ) is a plus.In-depth knowledge of FDA and EU regulations and ICH Guidelines.Strong technical mastery, analytical and investigation skills.Accurate in execution and reporting, quality-minded.Able to work effectively together with both internal and external stakeholders.Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.Able to work effectively together with both internal and external stakeholders.Fluent in English – our working language.Offer:
A competitive salary package with extensive benefitsFront seat in the development of therapeutic antibodiesA work environment in a human-sized, dynamic and rapidly growing biotech companyPossibility to work remotely with limited travelling requiredApply:
Your application and related information will remain strictly confidential.
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