Quality Assurance Specialist
Primary purpose of the role
·Supporting an efficient and smooth distribution of high-quality products to the market.
·Responsible for compliance to regulatory requirements for wholesale distribution of medicinal products, diagnostics and medical devices for the different customers of the DHL Pharma Logistics NV site of Huizingen/Lot.
·Supporting the QA Manager in the maintenance and improvement of quality standards, in line with regulatory and customer requirements. Advising in the translation of GMP, GDP, ISO and customer requirements in processes, procedures and instructions. Supporting operations in the investigation of issues and advising for the corrective and preventive actions to prevent reoccurrence. Participating in risk assessment exercises.
Batch release: To prepare the dossiers needed by the delegated QP/RP for the release of products. An emphasis on product quality and compliance is required above all, but this needs to be combined with attention for lead times, logistic priorities, and timely communication in case of potential supply issues as a result of quality-related issues.
Legal permits and agreements: To perform the administration needed to obtain the necessary legal permits and declarations needed for release of goods into Europe and wholesale distribution activities.
Returned Goods handling: To execute assessments of the product quality of returned goods and document accordingly.
Deviation resolution: Handling of temperature excursions: to prepare an immediate and correct impact assessment of temperature excursions on product.
Deviation, CAPA and change handling, participating in risk assessments.
Customer care: Providing support to various internal and external customers.
Environmental Monitoring, pest control, cleaning: To authorize the environmental data generated in the distribution operations and to access potential product impact of potential excursions. To authorize the pest control and cleaning schedules for the site.
- Quality Systems: To support the implementation of the quality systems needed in the operations. The warehouse receives drug products from our client(s). These drug products are then distributed to the BeNeLux.
Industrial Pharmacist (= must)
Preferably 3 year experience in Pharmaceutical Industry in a QA role but experience is not a must.
Operational knowledge of good distribution practices and regulations
Knowledge of quality techniques and quality management systems
Knows to combine accuracy with urgency
Prepared to take responsibility
Is able to deal with changing priorities in a flexible manner
Excellent written and spoken Dutch, French and English.
Be able to work individually and independently within a team
How to apply:
Please apply directly Nathan.email@example.com with your resume & motivation.
Facts and Figures
DHL Supply Chain Belgium
Work Permit Required