Quality Assurance GMP
The Company
Our client is a global biotechnology company specializing in innovative therapies. Renowned for groundbreaking research in life-changing treatments. Committed to improving patients’ lives through cutting-edge science. A leading force in the healthcare industry, driving advancements worldwide.
Role Description
As a Quality Assurance GMP you will apply specialized knowledge and analytical skills to solve complex technical problems, ensuring compliance and continuous learning. Works independently with guidance from department objectives, setting project priorities as needed and escalating issues when necessary.
Responsibilities

• Initiate and take ownership of minor deviations pertaining to Complaints Lab activities.
• Offer Quality Assurance oversight for Regulatory labeling within the Warehouse.
• Authorize destruction processes as necessary.
• Take responsibility for training materials related to PCI (Product Complaint Investigations) processes.
• Prepare, review, and approve procedures or work instructions in adherence to corporate, site, and regulatory requirements.
• Assist in projects and improvement initiatives as required.
• Deliver training staff on conducting investigations and assessments.
• Participate in regulatory inspections of the complaint sample handling process at the site and engage in audits, both internal and third-party, as needed.
• Furthermore, develop expertise in product complaint inspections and engage with relevant stakeholders.
• This role may involve cross-training in other quality departments, such as Plant QA, Warehouse QA, Clinical QA, and others, as deemed necessary.

Requirement

• A Master’s degree in Life Sciences or a related field, or an equivalent combination of education and experience.
• 0-1 year of relevant work experience.
• Proficiency in Quality Assurance within the pharmaceutical industry.
• Possesses a precise mindset, displays flexibility, and maintains a proactive attitude.
• Fluent in both Dutch and English languages.

Other information
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