Quality Assurance Associate

Context

Nuclear medicine has evolved considerably over recent years with the emergence of radiotherapeutics used in the treatment of cancers. The principle is based on the fact that radiotherapeutics can bring radioisotopes to the cancer cells which when they decay, emit radiation that destroys selectively the tumour. Among these therapeutic radioisotopes, one of the most promising is the alpha-emitting Actinium-225 which is used in the development of new radiotherapeutics by many pharmaceutical companies.

One of the main challenges is to make this radioisotope available in high quality in large quantities. By joining their unique expertise and resources SCK-CEN and IBA have launched the company PanTera which aims at enabling the production of Actinium-225 and make it available for the pharmaceutical industry.

Job Summary

We are seeking an experienced QA associate to join our quality team. The ideal candidate will have a strong background in quality assurance, a keen eye for detail, and a deep understanding of industry regulations. This role is crucial in ensuring our products meet the highest standards of quality and compliance, thereby maintaining customer satisfaction and regulatory adherence.

The QA associate works closely with various departments, including production and Quality control, to ensure that the day-to-day quality assurance activities are carried out efficiently and effectively. Key responsibilities include release of incoming raw materials, supplier management activities, root cause analysis, batch record review and managing the archive of quality records.

The ideal candidate will have a strong background in quality assurance within a manufacturing environment, excellent analytical skills, and the ability to communicate effectively with both internal teams and external suppliers.

Key Responsibilities

• Batch record review, including deviations and CAPA’s
• Release of incoming raw materials
• Supplier management activities
• Continuous improvement including training, changes and management review.
• Manage the archive of quality records to ensure they are properly stored, organized, and easily retrievable.

Profile

• Bachelor degree in Chemistry, Engineering, or a related field
• Minimum 3 years of experience in quality assurance, preferably within manufacturing in the pharmaceutical or radioisotopes industry.
• Experience in working in a GMP/GDP environment is a plus

Skills and Competencies:

• In-depth understanding of quality assurance principles and methodologies.
• Familiarity with regulatory requirements and industry standards (e.g., ISO 9001, cGMP, FDA).
• Excellent attention to detail and analytical skills.
• Strong written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Quick learner and able to work in a fast-changing environment
• Willingness to work in a controlled environment with adherence to strict safety and regulatory protocols.

Our offer

• Unique opportunity to work in a cutting-edge environment, contributing to the production of critical products used in the fight against cancer
• Collaborative work environment with supportive colleagues who prioritize teamwork
• Thriving start-up company with a dynamic entrepreneurial culture
• Work for a company that is dedicated to enhancing the quality of life for patients and making a difference in the healthcare industry.