Qualified Person II

Doorsturen
 
  • Vakgebied Quality & Safety
  • Dienstverband Fulltime
  • Vacaturenummer VAC-10005069
  • Locatie Haarlem
  • Type overeenkomst Secondment via YER
  • Branche Food, Feed, Pharma

Over deze vacature

Great opportunity for a Qualified Person! Do you speak fluent French and English? Are you interested in giving support towards Distribution & Logistics (EMEA) and the In-Market Quality organisation in Belgium? Do you have a background in chemistry, pharmacy, biology or microbiology? We would love to speak to you!

Functie

Reporting into the Associate Director D&L Quality EMEA lead, you will support both the Distribution & Logistics EMEA team and the Belgium In-Market Quality organisation, to ensure that all products are handled and transported in accordance with all applicable regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations.

You will support to ensure the quality performance of transportation and distribution. This includes overseeing activities such as Partner Selection and GDP Due Diligence, establishing Quality Agreements and ensuring permanent audit readiness. You will work in close cooperation with Quality and Supply Chain network to ensure quality performance of the transportation is consistent, providing support to build effective quality systems at the partner and supporting continuous improvement activities.

Next to the responsibilities mentioned above you will:

  • Repackaging Activities: Provide instructions for repackaging activities, review and  approve documentation, follow-up with the GMP supplier as applicable.
  • Complaints and customer queries: to coordinate with the subsidiary point of contact (DPOC) the responses to the healthcare professionals and/or patients.
  • Support in the preparation of the Quality Council.
  • Deviations: As applicable, support the Quality unit during the investigation processes and documentation of it.
  • Corrective and Preventive Actions CAPAs: As applicable, for the listed processes, support on the follow-up of actions.
  • Support during self-inspections.

This position can be based in Haarlem (The Netherlands), and requires travelling (20% of the time) in the EMEA- region (mainly to Brussels).

Bedrijf

For more than 125 years, our client has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives.

They demonstrate commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships.

Today, they continue to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases, such as HIV and Ebola, and emerging animal diseases.


Aanbod

  • Good base salary
  • Excellent secondary benefits
  • Holiday payment
  • 25 holidays
  • Travel allowance

Profiel

Desired skills and experience:

  • Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology
  • Prior experience in Pharmaceutical Industry, minimum 2 years in a Quality  Assurance role in GxP environment (GMP or GDP), preferable prior experience in GDP for distribution activities.
  • Strong knowledge in Good Manufacturing and/or Good Distribution Practices and knowledge in Quality Risk Management principles.
  • Problem solving skills based on science, data and understanding of the regulatory requirements.
  • Effective written and verbal communication skills.
  • High level in English verbal and written.
  • Fluent in French and/or Dutch, verbal and written.
  • Demonstrate values Ethics & Integrity, Courage, Deliver Customer Value.
Doorsturen