Quality Assurance Specialist Breda • SIRE Life Sciences

The Company
Our client is a global leader in the biopharmaceutical industry, dedicated to making a significant impact on the health and well-being of millions of people worldwide. With a strong commitment to advancing scientific discovery and high-quality medicines, the company’s focus is on delivering innovative products that meet the highest regulatory standards. Based in Breda, our client is looking for a talented professional to join their team and contribute to their vision.
 
The Role
As a Quality Assurance Specialist, you will be responsible for performing complaint assessments in line with internal procedures, regulatory guidelines, and business objectives. Your role will include managing minor deviations, overseeing training materials, and maintaining departmental performance boards. You will partner with various teams to support product complaint investigations and contribute to continuous improvement efforts across the site.
 
Key Responsibilities
-Initiate and manage minor deviations related to Product Complaint Inspection (PCI) activities.
-Own and update training materials and work instructions for PCI processes.
-Prepare and maintain departmental performance metrics and performance boards.
-Conduct assessments in support of complaint investigations, including Return sample inspection and Safety Features verification.
-Collaborate with corporate product quality surveillance, assessors from other Amgen sites, and contracted partners to resolve product complaint investigations.
-Review and approve procedures and work instructions in compliance with corporate, site, and regulatory requirements.
-Assist in  projects and improvement efforts as needed.
-Provide training to affiliate staff on performing investigations and assessments.
-Participate in site regulatory inspections and audits (internal and third-party) related to complaint sample handling processes.
-Develop expertise in product complaint inspections and collaborate with related stakeholders.
 
Requirements
-MBO or Bachelor’s degree in Life Sciences or a related field (or equivalent combination of education and/or experience).
-Knowledge of GMP and GDP, with the ability to interpret and apply these principles in both routine and non-routine situations.
-Understanding of Complaints Management, Deviations, and Quality processes and systems.
-Fluent in English.
-At least 2 years of practical experience in Good Manufacturing Practice (GMP) within a pharmaceutical environment.
-At least 2 years of experience in Quality Assurance or a related field.
-Experience in investigations, deviations, and Quality systems is a plus.
 
Other Information
If this role aligns with your experience and career goals, we’d love to hear from you. If not, feel free to share it with your network!
 

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