Vacature detail

(Junior) Quality Assurance Manager
About usArdena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development services.The Ardena Group is operating from seven sites in Europe. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a(JUNIOR) QUALITY ASSURANCE MANAGER YOUR KEY ROLEArdena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.The Quality Assurance group plays a key role in ensuring manufacturing of investigation medicinal products (IMPs), according GMP, with respect of appropriate designed workflows and processes.YOUR KEY RESPONSIBILITIESThe Quality Assurance Manager is responsible for day-to-day implementation of the Pharmaceutical Quality System in the organization. Drafts and keeps up to date the procedures and process flows related to non-sterile as well as sterile manufacturing.Provides or supports in training of the personnel for what concerns the Quality processes and GMP awareness.Responsible for the daily follow up of the pharmaceutical management system: deviations, changes, CAPAs, complaints, supplier qualification, logbooks, equipment qualification, destructions, shipments, reference and retention samples.Assists during contractor audits, contract giver audits and performs internal audits.Assists the Qualified Person in the preparation of the batch certifications.Reviews and approves master and executed documents (e.g. Batch Record Documentation, Incoming Material Records, Product Manufacturing Records).YOUR PROFILEYou have a Master degree in Pharmaceutical Sciences.You have knowledge of GMP quality system and regulatory requirementsA first experience in Quality Assurance in pharma is a plus.You are solution driven, keeping timelines and budget in mind.You are continuously looking for improvement.You have strong communication skills, able to listen and analyze a quality issue and explaining the proposed solution in an accurate manner.You are able to manage the QA support on multiple projects, and like participating in project teams.WE OFFERAn attractive and tailor-made remuneration package including extra-legal benefits such asCompensation if you come to work by bikeDaily meal vouchersGroup/hospitalization insurance Flexible working hours32 days holiday per yearAbility to grow your skills in a rapidly growing company with international customer portfolioA dynamic working environment
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Oost-Vlaanderen, Ghent
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