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 disintegrate, emit radiation that destroys selectively the tumour. Among this therapeutic isotopes, 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 specializing in Qualification and Validation 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 (Qualification & Validation) ensures that equipment, systems, processes and facilities comply with regulatory standards and internal quality requirements. This role mainly supports validation activities, documents qualification efforts, and collaborates with cross-functional teams to maintain product quality and regulatory compliance.

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

Qualification and Validation :

• Support creation and document qualification and validation documents including protocols, master plans, …
• Support validation lifecycle activities, including risk assessments, test plan creation, execution, and summary reporting
• Review and approve validation protocols and reports to ensure completeness and accuracy

Compliance and Documentation :

• Develop and maintain SOPs related to qualification and validation activities
• Assist in audit preparation and participate in internal audits as needed.

Cross-Functional collaboration

• Work closely with engineering, manufacturing, and R&D teams to ensure proper qualification of equipment
• Provide QA oversight for validation activities conducted by third party vendors or contractors
• Train and guide team members on validation processes

Team Support and Backup :

• Act as a backup for other QA team members, providing support during absences or peak workload periods
• Stay familiar with broader QA functions to ensure smooth operations across the Quality department.

Profile

• Bachelor degree in Life Sciences, Chemistry, Engineering, or a related field
• Minimum 5 years of experience in a quality assurance and validation role in the pharmaceutical, industry.
• Strong understanding of validation principles, regulatory requirements, and quality systems.
• Experience with software validation (CSV) is a plus
• Knowledge of risk management tools and methodologies (e.g. FMEA)

Skills and Competencies:

• Excellent organizational skills
• Excellent attention to detail and analytical skills.
• Strong written and verbal communication skills.
• Ability to work independently in a collaborative team environment.
• 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
• Company dedicated to enhancing the quality of life for patients and making a difference in the healthcare industry.