Senior QA Associate Maternity Cover Breda • Hays

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Your new companyOur client is a values-based organisation with a powerful sense of shared purpose towards their mission: to serve patients. They provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked their early days as a biotechnology innovator. They encourage team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this job opportunity.
At our client’s Breda site, The Netherlands, medicines are labelled, assembled, stored, and eventually shipped to various countries worldwide. Every day, more than 1,000 people of 38 different nationalities work on supply chain processes, manufacturing, marketing and sales of medicines, and clinical research into new treatments.

Your new role
As a Sr. Associate QA, you will provide quality oversight for the clinical supply chain and support production activities at our client’s Breda site. You’ll ensure compliance for clinical trial products received and distributed to global sites and depots, while building strong relationships with cross-functional stakeholders.
Your key responsibilities include:

• QA support for Investigational Medicinal Products, ensuring GDP and GMP standards are met
• Batch record review to support QP certification in line with EU and international regulations
• Compliance review and approval of clinical label artwork
• Assessment of temperature excursions during transport and at clinical sites
• Resolution of quality and compliance issues related to manufacturing and logistics
• Review and approval of minor deviations per procedural requirements
• Ownership and creation of SOPs and Work Instructions
• SOP review to ensure alignment with corporate, site, and regulatory standards
• Preparation of monthly QA metrics
• Cross-functional issue identification and resolution
  

• Typically, 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing.
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) knowledge
• Fluent in English.
• You are bursting with energy, and you cannot wait to start working.
• You are eager to learn, like to show initiative, and you are ambitious about your goals.
• Compliance following attitude with a high degree of attention to detail.
• Effective communication skills and ability to work in cross-functional teams
• Problem-solving skills, including critical thinking and analytical reasoning
  
  
  
  What you'll get in return
  This is a maternity cover role for our client, with a contract via Hays. Extension or takeover cannot be guaranteed at this time. In this position you will receive a salary beginning from 4,3000euro gross per month, and your travel expenses will be covered. Due to our relocation policy, we can only consider candidates who reside in the Netherlands or live within a commuting distance from Breda for this vacancy.
  
  
  
  What you need to do now
  If you are interested in this role, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion about your career.