As a strongSenior Quality Assurance Associate – Clinical Supply Chain /strong, you will be responsible for ensuring that medicines used in clinical trials meet the required quality and regulatory standards.br /You will oversee quality processes related to the packaging, labelling, storage and distribution of clinical trial products. You will also work closely with departments such as Production, Warehouse, Supply Chain, Quality and Regulatory Affairs to ensure compliance throughout the entire process.br /strongYour main responsibilities will include: /strongulliReviewing batch documentation to support the certification and release of investigational medicinal products in accordance with EU and international regulations. /liliReviewing and approving clinical trial label artwork to ensure compliance with regulatory requirements. /liliAssessing temperature deviations during transportation and storage at clinical sites. /liliInvestigating and resolving quality and compliance issues related to the manufacturing and distribution of clinical products. /liliReviewing and approving minor deviations, ensuring that all procedures and regulatory requirements are followed. /liliCreating, updating and reviewing Standard Operating Procedures (SOPs) and Work Instructions. /liliPreparing monthly quality reports and monitoring key performance indicators. /liliCollaborating with different departments to identify quality risks and implement improvements. /liliProviding hands-on Quality Assurance support during clinical packaging and labelling activities, including packaging checks, batch record reviews and resolving quality-related issues. /liliPerforming QA compliance checks to ensure that GMP and GDP standards are consistently maintained. /li /ulbr /Please note that we are unable to consider candidates who require visa sponsorship or who live too far from the work location. Candidates who would need to relocate can only be considered if they have already secured accommodation within a reasonable commuting distance.H3Requirements /H3ulliA Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or a related scientific field. /liliApproximately 3 years of relevant experience in Quality Assurance or manufacturing within the pharmaceutical or medical device industry. /liliExperience with batch record reviews, quality investigations and/or analytical testing. /liliGood knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP). /liliExcellent English communication skills, both written and spoken (C1 level). /liliStrong attention to detail and a quality-focused mindset. /liliGood analytical and problem-solving skills. /liliThe ability to communicate effectively and collaborate with different departments. /liliA proactive attitude, willingness to learn and ability to take ownership of responsibilities. /liliCurrently residing in the Netherlands or within a reasonable commuting distance of Breda. /li /ulbr /H3Benefits /H3ulliThis is a 1-year contract position through Undutchables /lili Working hours: Full-time (40 hours/week) /liliCompetitive salary package. /liliPension scheme /liliTravel expense reimbursement, dependent on distance. /liliDynamic, international, and collaborative work environment with excellent development opportunities. /li /ulH3Application Procedure /h3If you are interested in this vacancy, you can apply by clicking on the button above. By clicking on apply, you agree to our a privacy commitment /a and a terms and conditions /a. Your application will be sent directly to the recruiter in charge. IMPORTANT: if you are not yet registered with Undutchables we kindly ask you to do so. Your information will be handled in the strictest confidence and your CV will not be sent to a company unless you have given prior permission. Curious about how the recruitment process works within Undutchables, a click here /a to read more.