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 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 pharmaceutical 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 is responsible that product and process related investigations, complaints, batch review and release activities are properly handled on time and in line with GMP requirements. The QA Associate 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 pharmaceutical manufacturing environment, excellent analytical skills, and the ability to communicate effectively with both internal teams and external suppliers.

Key Responsibilities

Training delivery: support in training development for GMP introduction training for new employees and/or other quality-related training sessions (e.g. deviations, CAPA, documentation practices), to ensure personnel understand and comply with current Good Manufacturing Practices and internal quality procedures.

Support in investigations: Provide assistance in the timely and thorough investigation of deviations, complaints, OOS/OOT results, and other quality-related issues, ensuring accurate documentation and appropriate follow-up actions.

Deviations and complaints management: Ensure that deviations and customer complaints are recorded, investigated and resolved in a timely and compliant manner. Escalate issues that could have significant impact product quality, regulatory compliance or patient safety.

CAPA management: Coordinate and track the implementation of Corrective and Preventive Actions (CAPAs) to address root causes identified through investigations. Monitor CAPA effectiveness and ensure timely closure.

Audit/Inspection support: Support the preparation, execution, and follow-up of internal audits, regulatory inspections, and customer quality audits. Assist in maintaining a state of inspection readiness and responding to audit observations.

Support in change management: Provide input and support for change management processes, including reviewing and assessing proposed changes for potential quality and compliance impact.

Batch documentation review: Review batch manufacturing records, packaging records and QC documentation to confirm compliance with internal procedures and regulatory requirements prior to product release.

Supplier Qualification & management: Support the qualification, evaluation and monitoring of suppliers and service providers to ensure they meet regulatory and company quality standards. Participate in supplier audits, review supplier documentation (e.g. questionnaires, certifications, audit reports), and help maintain the approved supplier list.

Collaboration and stakeholder engagement: Build and maintain strong cross-functional relationships with internal departments (e.g.,Manufacturing, QC, Engineering, transport,.... and external partners to ensure alignment on quality standards and expectations.

Team Support and backup : Act as a backup for other QA team members, providing support during absences or peak workload periods. Contribute to team goals and continuous improvement initiatives.

Profile

• Bachelor degree in Life Sciences, Chemistry, Engineering, or a related field
• Minimum 5 years of experience in a quality assurance role in the pharmaceutical, industry.
• Strong understanding of regulatory requirements and quality systems.
• 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 nuclear and pharmaceutical 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.