Quality Control Officer Baarle-Nassau • Talentmark

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Quality Control OfficerLocation: Baarle Nassau

Are you detail-oriented, scientifically driven, and passionate about pharmaceutical quality? We are looking for a Quality Control Officer who will play a vital role in ensuring the integrity, safety, and compliance of our cutting-edge radiopharmaceutical products.

Your Purpose As a Quality Control Officer, you are instrumental in executing and overseeing quality control processes in accordance with GMP standards, Standard Operating Procedures (SOPs), Work Instructions, and analytical methods as defined in our quality system.
You bring in-depth expertise in analytical methodologies within a GMP-regulated laboratory environment and serve as a Subject Matter Expert in quality control systems, investigations, and qualification activities.

Key Responsibilities

• Perform accurate and timely quality control testing of raw materials, intermediates, and finished products in line with approved specifications and methods.
• Recognize and immediately report any anomalies or deviations during testing to the Qualified Person.
• Conduct routine QC testing following established analytical procedures.
• Execute sampling, review, and documentation of environmental monitoring in line with the site’s environmental control program. Analyze data and perform trending.
• Manage the lifecycle of QC documents, including generation, qualification execution, review, and approval. Escalate delays or issues to management as needed.
• Collaborate with Analytical Science & Technology (AS&T) on validation, revalidation, project management, and technology transfer related to lab equipment.
• Coordinate and manage deviation, out-of-specification (OOS), and out-of-expectation (OOX) investigations, ensuring timely resolution and documentation.
• Support broader qualification activities, including change control, equipment calibration, preventive maintenance, system configuration, and SOP development.
• Identify and communicate opportunities for improvement in methods, equipment, or systems in line with GMP and business needs.
• Ensure the QC laboratory remains organized, clean, and audit-ready at all times.
• Comply strictly with all radiation safety and general safety protocols, preventing exposure risks for self or colleagues.

Key Performance Indicators (KPIs)

• All QC activities are compliant with GMP, GDP, and internal Novartis standards.
• 100% of product batches are tested and released on time with the required quality.
• Qualification and validation activities are performed accurately and within deadlines.
• Investigations (deviations and OOS/OOX) are thoroughly conducted and closed in a timely manner.

Your ProfileEducation:

• Bachelor’s degree (or equivalent) in Chemistry, Biochemistry, Microbiology, or a related life sciences field.

Experience:

• At least 1 year of experience in a (radio)pharmaceutical QC laboratory or equivalent role within a highly regulated industry.
• Strong knowledge of cGMP and Good Laboratory Practices (GLP).
• Analytical mindset with a high level of accuracy and attention to detail.
• Eagerness to adopt new technologies and a proactive approach to continuous improvement.
• Strong interpersonal and communication skills, with the ability to collaborate effectively across teams and with external partners.
• Demonstrates a strong sense of ownership and urgency in completing tasks.

Languages:

• Fluent in English (spoken and written). Dutch is a strong plus.