Quality Assurance Specialist Fulltime
XDES Projects - Haarlem
Quality Assurance Specialist – Fulltime in Haarlem // Quality Assurance Netherlands, Haarlem Fulltime V- Competitive Ben jij een proactieve en analytische starter met een passie voor kwaliteitsbewaking? In Haarlem zoeken - Volledige vacature bekijken
Quality Assurance Manager
Netherlands, Hoofddorp
februari 27, 2025
Fulltime
V-117998-1
Competitive
The Client:
Is a mid-size privately-owned international pharmaceutical company which focuses on the development and commercialization of niche hospital and orphan products to address unmet medical needs. Their expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development. Today, they have a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: Rheumatology, Women’s Health, Ophthalmology and Critical Care.The Job:
Among your activities, you will oversee a portfolio of products representing 30% of the turnover of product requiring the supervision of 3 finish product manufacturers and 3 active ingredient suppliers. For this portfolio you will be responsible for the management of major pharmaceutical projects (technological transfers, new launches change in packaging).- Participate in maintenance of the implemented Quality Management System for all global products
- Quality surveillance of contractors/partners involved in GxP activities
- Follow-up on quality complaints, managed by the Quality Assurance Associate
- Conduct the internal and external audits under GMP/GDP
- Oversee the maintenance of the quality documentation, define/review the controlled documents, deliver quality trainings, and manage the EDMS
- Ensure the follow up of all changes implemented to CMOs, with impact evaluation and project management (transfer, new manufacturers etc.)
- Preparation and participation in the Competent Authorities’ inspections (GxP)
The Ideal Candidate:
- Scientific education (master’s degree) or Pharmacist with specialisation in quality assurance
- The knowledge of Quality Control and batch release
- Experience at QC laboratory and/or manufacturing site is necessary
- Minimum 5 to 7 years of experience in the GMP/GDP quality pharmaceutical environment
- Realization of external /internal audits as lead auditor
- Fluent English (spoken and written)
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