QP/Qualified Person

Aussicht: 100

Update Tag: 07-11-2025

Ort: Braine-l’Alleud Walloon Brabant

Kategorie: Wissenschaft Beratung / Kundenservice Qualitätssicherung / Qualitätskontrolle

Industrie: Pharmaceutical Manufacturing

Position: Associate

Jobtyp: Full-time

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Jobinhalt

We are looking for a Development Quality Partner Pharma Sciences Ops & QP for one of our clients based in Braine-l’Alleud.

This is a contract as a Consultant (employee or freelance): project from “September 2024” to” December 2025”.

Job description :

The Development Quality Partner Pharma Sciences Ops & QP will be responsable for :

Supporting the manufacturing operational activities.
Supporting the manufacturing operational activities for the External Manufacturing Vendors and Partners (quality oversight and management of development operational set-up activities, batch record review, release).
Ensure all these activities meet regulatory requirements and expectations and delivers business performance.
Actively participate in the selection, evaluation and approval of third-party contractors for Development activities, including support for the conduct of appropriate audits and the ongoing QA relationship management to assure compliance with the client and current and expected future regulatory standards and expectations.
Partnering with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations/deviations/out-of-specifications) that may affect client’s development activities and products.
Acting as a Qualified Person according to new Directive 536/2014 for Investigational Medicinal Products (IMP) and responsible for the management of batch disposition and release activities concerning the provision of DS and DP for client’s sponsored clinical trials.
Providing QP Certification of manufacturing sites used in the production of Development Products. As Qualified Person for batch release activities, work in closed collaboration with CTS QP ’s who are responsible for final IMP batch release activities under the 194IMP.

Requirements :

QP with minimum 5 years’ experience in pharmaceutical regulated environment.
Must be knowledgeable in QA and technical requirements of pharmaceutical development processes.
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
Experience in participation in the management of regulatory inspections including PAI.
QA/compliance experience in IMP manufacturing, facility operation, laboratory compliance and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences.

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