Senior Specialist Quality Assurance Haarlem • MSD Nederland

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Job Description

Ensure life-saving treatments reach patients worldwide by managing clinical trial material distribution. Make a real impact in global health: oversee our clinical supply chain.

At location Haarlem we have an exciting opportunity for a: Senior Specialist Quality Assurance

Welcome to our team

The Global Development Quality (GDQ) organization is responsible for providing quality oversight of internal clinical packaging and distribution operations and supply chain management support for the end-to-end clinical supply chain. Our team partners broadly across our company and our external partners to deliver continuous current good manufacturing practices (cGMP)-compliant clinical supply on time, every time, across the globe.

Purpose of the position

This role is essential for ensuring the smooth operation of our global clinical supply chain. You'll achieve this by overseeing and managing the disposition of clinical finished goods used in worldwide clinical trials. Reporting to the Associate Director, Global Development Quality, you'll be a key member of the Global Development Quality (GDQ) team.

In addition to your core responsibilities, you'll also be involved in supporting the GMP Quality Assurance activities for the GDQ IMP (Investigational Medicinal Product) License at the Global Clinical Supply (GCS) Warehouse and Distribution depot in Haarlem. This includes contributing to the design and oversight of the quality management system for the warehouse and distribution of clinical supplies.

Primary responsibilities

• Provide Pharmaceutical Expertise: Advise Haarlem operations on technical knowledge related to product quality, including the effects of process changes/deviations and external guidelines. Develop and maintain pharmaceutical policies and procedures, approve deviations, and authorize GMP documentation.

• Ensure GMP Compliance: Guide Haarlem operations on GMP inspections and ensure readiness. Monitor compliance of GCS operations activities, take necessary actions, and contribute to resolving complex quality issues.

• Lead Quality Improvement: Initiate proposals/business cases for quality improvement projects, including planning and implementation. Monitor activities concerning compliance and take corrective actions.

• Manage Data and Documentation: Implement and ensure data review, analysis, and documentation (e.g., SOPs). Initiate and oversee completion of subsequent actions.

• Contribute to Operational Quality: Prioritize, initiate, and monitor agreed-upon quality improvements in operations.

• Perform Quality Control Activities: Review customer complaints, manage deviation processes, control changes, set up project documentation, develop CPVs, and prepare annual reviews.

• Data Analysis and Reporting: Compile data for reports and presentations, interpret data, and draw conclusions.

Your profile

• A minimum of 5 years of experience in the pharmaceutical industry with a strong background in Quality Assurance (QA).

• Prior experience in manufacturing operations is a plus, especially if it involved logistics and continuous improvement initiatives.

• A solid understanding of EU GMP and cGMP requirements is essential.

• Fluency in both Dutch and English, written and spoken, is required.

• You're a team player who thrives in collaborative environments and actively participates in cross-functional improvement initiatives.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end bonus;
• 35,5 days of leave;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• Incentive Plan;
• Travel allowance for commuting;
• On-site sports facilities;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

For questions about this vacancy
Please send an email including the vacancy number and job title to the following email address:via de button "Solliciteer nu" op deze pagina..

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Requisition ID:R355145