Vacature

Deputy QP/QA Specialist

About DHL Pharma Logistics:Our warehouse receives drug products from ...

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


Your Profile:


        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.van_den_branden@dhl.com.



Sollicitatieprocedure

Stap1
Eerste Selectie
Stap2
Telefonisch Interview
Stap3
Gesprek Op Kantoor
Stap4
Arbeids-voorwaarden
Stap5
Welkom bij DHL

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