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Project Quality Assurance Validation Engineer

Posted 25 Mar 2024
Work experience
3 to 5 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Fluent)
Dutch (Fluent)

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Job Description

Cancer is one of the greatest challenges of our time. In the Netherlands, approximately 116,000 people are diagnosed with cancer every year. On a global scale, 1 in 6 people lose their life to the illness.

As the largest pharmaceutical company in the Netherlands we would like to hereby announce that we are doubling our capacity for biotech production in Oss in the coming years. The expansion is needed because of the worldwide growing demand for treatments against various types of cancer. With the increasing capacity and new facilities, we can deliver medicines to the rest of Europe and in the future also to China and the United States.

Because of this growth, we have a position open for a:

Project Quality Assurance Validation Engineer

About this role

The main areas of expertise are in, but not limited to specific task and roles, Qualification & Validation, internal and external inspection and auditing, supplier management including contracts and agreements, quality systems management, document / SOP management and inter site business, GMP & Validation training and knowledge management, regulatory affairs and authority liaison function.

This with the objective to ensure efficient and effective compliant design, construction, qualification, approval and operation of the new assets and you contribute to the project to maintains alignment with Quality and Compliance principles of the site.

In this role you will play a key role in guiding and upholding Qualification & Validation Compliance in the development, project execution and startup of the new build facilities Capex Project to extend processes capability for Drug Substance manufacturing at Oss Biotech.

The Project Quality Assurance Validation Engineer ensures that the Qualification & Validation Methodology will be applied and executed according to company standards throughout the phases of the project.

Responsibilities

  • Collaborating with stakeholders (e.g. Core Project Team members, Owners, Process Owners, Data Owner) to assess facilities, utilities, equipment, process and automated (IT) systems to support GMP business processes; to ensure technologies selected meet the Quality Standards to reduce Risks to an acceptable level for upholding Product Quality & Compliance;
  • Providing the independent quality oversight roll regarding Qualification & Validation as per QMS standards;
  • Assuring Site Project / Above Site Functions have Qualification & Validation documentation approved by Quality, in place and followed to ensure compliance;
  • Initiating, facilitating and reviewing Qualification & Validation documentation and their supporting documentary evidence to verify that the Validation & Qualification project process is in place and effective;
  • Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to the applied Qualification & Validation mythology and taking appropriate actions to ensure GMP compliance;
  • Driving resolution to effective mitigation of identifies non-compliancy’s;
  • Monitoring and communicating Qualification & Validation program project status health, compliance and other metrics updates to key stakeholders;
  • Promoting GMP and Qualification & Validation awareness and a culture to continuously improve facilities, utilities, equipment, process and automated (IT) systems manufacturing processes, including latest trends in Qualification & Validation methodology and best practices;
  • Representing Qualification & Validation upon request in the Site Project / Above Site Functions;
  • Contribute in the development and execution of project training programs in the principles of Qualification & Validation methodology.

MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de…


MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de diepte, door je te specialiseren in je vak. Maar ook door jezelf te verbreden en door te groeien naar een leidinggevende functie. Internationaal of juist heel lokaal, er zijn talloze andere mogelijkheden om stappen te zetten in je loopbaan, te rouleren in functies of te groeien in je functie. Werken bij MSD is werken in een dynamische high tech omgeving van internationale allure, die toch sterk lokaal geworteld is in Oss, Haarlem en Boxmeer.

Pharmaceutical
Haarlem
5,600 employees