About DHL Pharma Logistics:
Our warehouse receives drug products from our clients which are distributed to more than 90 countries in the world. We are also managing the detail distribution of these drug products to wholesalers, pharmacies and hospitals in Belgium, the Netherlands and Luxembourg.
Primary Purpose of the Role
Assist the GDP Responsible Person (RP) and the Qualified Person (QP) by monitoring and guaranteeing the strict respect of regulatory affairs for the storage and distribution of pharmaceutical and healthcare products. Act as responsible person and qualified person ad interim in all case RP/QP is absent.
Main Tasks of the QA Specialist/Deputy QP:
• Assist the RP/QP in ensuring the compliance of activities with relative legislation, GxP and technical agreements throughout all business processes
o check the status (released/not released) of incoming and stored medicinal products/healthcare products + manage that status changes comply with applicable legislation
o be the QP for EU batch release of products listed on the appropirate annex of the licence
o manage the decision making process (disposal/return to saleable stock) for returned goods
o supervise the manufacturing activities according to current licence (secondary packaging, site of physical importation); be the QP for such activities when required
o Check pharmaceutical data of distributed products
o Ensure product recalls and establish incident reports
o Identify and separate accepted or rejected products
• Assist the RP/QP in ensuring follow-up of customers
• Assist the RP/QP in all contacts with the Federal Agency for medicinal and health products
• Support business development on pharmaceutical and regulatory issues ; assist with the drafting/review of technical agreements
• Contribute to the development of the ISO 9001 quality system
• Audit GxP subcontractors (ex: carriers)
• Assist the RP/QP in the follow-up of regulatory affairs in the area of drugs, medical devices, food products, biocides and cosmetics
• Assume fully RP/QP's duties during short or long absences
• Assist the RP/QP in all contacts with the RP/QP/QA manager/RA Manager representing the customer (= contract giver) companies
• Industrial Pharmacist in possession of a QP number.
• Minimum 5 years of experience in a QA-position, preferably in the Pharmaceutical-related Industry
• Operational knowledge of GDP- and GMP-regulations and Quality Management Systems
• Strong communication and coordination skills to bring together different stakeholders, to make clear agreements, to make proper adjustments when required, …
• Strong analytical skills to review and evaluate reports, registrations, processes, …
• Knows to combine high accuracy with urgency and changing priorities
• Problem-solver, prepared to take responsibility and ownership
• Excellent written and spoken Dutch and English, customer oriented
• Be able to work individually and independently, in combination with being a teamplayer as well
How to apply:
Please apply directly with your resume & motivation letter Nathan.email@example.com.