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.
Your main responsibilities will include:
- Reviewing batch documentation to support the certification and release of investigational medicinal products in accordance with EU and international regulations.
- Reviewing and approving clinical trial label artwork to ensure compliance with regulatory requirements.
- Assessing temperature deviations during transportation and storage at clinical sites.
- Investigating and resolving quality and compliance issues related to the manufacturing and distribution of clinical products.
- Reviewing and approving minor deviations, ensuring that all procedures and regulatory requirements are followed.
- Creating, updating and reviewing Standard Operating Procedures (SOPs) and Work Instructions.
- Preparing monthly quality reports and monitoring key performance indicators.
- Collaborating with different departments to identify quality risks and implement improvements.
- Providing hands-on Quality Assurance support during clinical packaging and labelling activities, including packaging checks, batch record reviews and resolving quality-related issues.
- Performing QA compliance checks to ensure that GMP and GDP standards are consistently maintained.
- A Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or a related scientific field.
- Approximately 3 years of relevant experience in Quality Assurance or manufacturing within the pharmaceutical or medical device industry.
- Experience with batch record reviews, quality investigations and/or analytical testing.
- Good knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP).
- Excellent English communication skills, both written and spoken (C1 level).
- Strong attention to detail and a quality-focused mindset.
- Good analytical and problem-solving skills.
- The ability to communicate effectively and collaborate with different departments.
- A proactive attitude, willingness to learn and ability to take ownership of responsibilities.
- Currently residing in the Netherlands or within a reasonable commuting distance of Breda.
- This is a 1-year contract position through Undutchables
- Working hours: Full-time (40 hours/week)
- Competitive salary package.
- Pension scheme
- Travel expense reimbursement, dependent on distance.
- Dynamic, international, and collaborative work environment with excellent development opportunities.
€4700.00 - €4800.00 monthly