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Qa qualification contractor

Anvers
Barrington James
Publiée le Publiée il y a 12 h
Description de l'offre

Fixed-term contract - Contract runs through to the end of 2026


Must speak English and Dutch


Office-based in Antwerp


Must have experience with manufacturing systems used within the pharma or chemical industry


These requirements are absolutely non-negotiable for the suitable candidate.


I am looking for an experienced QA Qualification Contractor to support qualification activities across manufacturing systems within a highly regulated environment. This is a confidential opportunity with a leading organisation and will suit someone who is confident working in a cross-functional setting and maintaining strong cGMP compliance standards.


Responsibilities

* Support the QA Engineering team in ensuring all qualification-related regulatory and procedural requirements are met throughout the full lifecycle of manufacturing systems, from concept and project stages through to operational use and retirement.
* Review and approve qualification documents and quality records, including SOPs, user requirements, impact and risk assessments, test plans, test scripts, change controls and CAPAs, to ensure compliance with applicable regulations, guidelines and internal standards.
* Work closely with engineering teams and other stakeholders to support the introduction of new or upgraded systems and processes.
* Provide advice and support in the preparation of qualification-related activities, while maintaining cGMP expectations.
* Manage and follow up deviations arising during qualification execution.
* Communicate quality, compliance and planning status to relevant QA Qualification team members.


Requirements

* Proven experience within the pharmaceutical or chemical industry in relation to the qualification of manufacturing systems.
* Fluent in both English and Dutch, written and spoken.
* Strong knowledge of cGMP regulations and guidelines.
* Ability to translate technical information into clear, understandable language at all levels of the organisation.
* Strong judgement in assessing urgency, criticality and the impact of decisions.
* Ability to manage multiple priorities and projects simultaneously.
* Capable of working independently as well as within a cross-functional team environment.
* Strong communication skills.
* University or Bachelor’s degree, or equivalent.
* Around 4–6 years’ relevant experience preferred.
* Experience with systems such as Trackwise, Comet, TruVault and Kneat would be advantageous.


How to apply

If you are interested in this opportunity, please send your CV to gjohnstone@barringtonjames.com or contact +441293778666 for a confidential conversation.


You are also welcome to get in touch directly via LinkedIn.

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