QA Officer GDP/GMP
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
·Supporting the efficient, qualitative and compliant storage- and distribution processes of pharmaceutical and healthcare products.
Main Tasks of the QA Officer Team:
·Perform QA-related checks, releases and stock-status-changes during operational processes:
olocal batch release: incoming inspection on products and documentation
ocreation of QA-documents for release of goods upon arrival at the destination-country
ohandling of returned goods
orework activities: approve the start of rework activities, follow up and perform in process controls as necessary and create Quality Dossiers when requested by the customer
oadministrative handling of controlled drugs, …
Align and follow-up with Operations in case of deviations on the required actions in order to limit the operational delays without jeopardizing compliance.
·Monitor, review and approve the QA-related aspects of the environmental monitoring processes (temperature control, pest control, cleaning, calibration, …), and follow-up the qualitative and on-time closure of actions in case of deviations.
·Responsible for the QA-related aspects of the document management process and its related training processes. Both processes are electronically set-up where the QA Officers should ensure proper maintenance of the data in the system (in case of new employees, new/revised procedures, …), monitor and report the status of these processes and provide support to other departments in case of questions on the day-to-day use of this software system.
·Coordinate customer specific Change Control requests, related to operational processes, to ensure proper and on-time implementation and monitor and report the status of these requests.
·Perform checks on the shopfloor when needed, to verify effectiveness of implemented actions.
·Provide administrative support during Authority, customer and Third Party audits.
·Bachelor degree, preferably in a scientific direction
·Minimum 3 years of experience in a QA-position, preferably in the Pharmaceutical-related Industry
·Strong communication skills, enabling alignment with both operational and supporting stakeholders
·Strong administrative skills (paper and electronic) and highly accurate
·Good analytical skills to review and evaluate operational steps, reports, registrations, …
·Good writing and speaking in 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 via the apply button on the website.
Zahlen und Fakten
Pharma Logistics NV
„Die Deutsche Post DHL bietet mir Sicherheit, die Chance mich weiterzuentwickeln und die Möglichkeit, in fast jedem Land der Welt zu arbeiten.“
Aktueller Mitarbeiter – Senior Consultant in Bonn