Quality Assurance Assistant (m/f/d)

3B Pharmaceuticals (3BP) is a leading developer of targeted molecular radiopharmaceuticals focusing on cancer indications with high medical need. The focus of our drug development programs is a theragnostic approach using diagnostic imaging to identify patients who are likely responders to radiopharmaceutical therapy. 3BP has built a unique technology platform for the efficient discovery and validation of cancer radiopharmaceuticals.

We are currently planning our first therapeutic clinical study with one of our proprietary therapeutic development candidates. In this context we are looking for a QA Assistant (m, f, d) to support existing GDP activities as well as the implementation of GCP.

Tasks

The Quality Assurance Assistant (QA-A) will support the existing QA team towards implementation of GCP compliance and further development of the existing GDP system. Activities include transfer of the quality management system to a digital platform and performing tasks according to existing SOPs, i.e. vendor qualification, CAPA management, deviation management, etc.. Furthermore, the QA-A will collaborate with the clinical operations team on activities of clinical trial set up including qualification of international clinical sites and radio-pharmacies and third-party selection. The QA-A will report to the Quality Manager.

The QA-A requires extensive experiences in quality management including having previously developed and worked under a GxP quality management system including SOP writing and process development. Proficiency in written and spoken English and German is required. Knowledge of GCP as well as electronic document management systems are beneficial. The QA-A must be experienced in managing external partners and have participated in at least one authority inspection; involvement in audits of third parties or self-inspections would be a bonus. The QA-A has experience supporting inspection readiness related to relevant operational processes. Mentorship and support will be available, although the QA-A should thrive with minimal direct supervision and a high degree of control over their own day-to-day activities.

The QA-A should be motivated by the opportunity to develop an existing QA system further. The candidate shall be confident performing quite different relevant tasks and communicating with various functions internally and externally. The candidate will be able to inspire others including the QA team and colleagues in the clinical and other operational teams and have a collaborative and open-minded style that fosters a supportive working environment for the team.

Key Responsibilities

• Optimization and development of the existing QM system according to GDP and GCP including writing SOPs
• Optimization and development of internal quality-related processes in collaboration with relevant departments
• Implementation of GDP- and GCP-related QA processes into an electronic document management system
• Coordination, support and evaluation of supplier qualification audits
• Performing QA related day-to-day activities as e.g. vendor qualifications, risk analyses, CAPAs as well as manage deviations and complaints
• Collaborating with the clinical operations team on the process of clinical site qualification as well as of radio-pharmacy units
• Management of consultants (e.g. for audits)
• Monitoring regulatory requirements and highlighting necessary adjustments to 3BP colleagues for implementation

Requirements

• Considerable quality management experience including writing, developing and working under SOPs
• Process development and optimization transfer into SOPs
• Proficient written and spoken German and English communication skills
• Experience in communication with and management of third-parties
• Insight into GxP quality management systems
• Previous participation in an authority GxP inspection
• Ability and willingness to establish and build internal relationships at all levels
• Highly developed communication skills
• Training as technical assistance or Bachelor Degree
• Right to live and work in Germany

Location and travel

The position is office-based in Berlin. Home-office work can be performed in agree-ment with the team. In addition, the QA-A will be required to travel domestically and internationally to visit vendors and partners as well as to support 3BP´s audit program.

Our Culture

• An open and appreciative corporate culture with a strong team spirit
• Attractive employment conditions in a growing company with flat hierarchies
• You work independently and self-responsible
• Permanent employment, flexible working time model
• Potential to develop your role as the company grows or requirements appear

1. If this appeals to you, we look forward to receiving your application documents with details of your previous work, the earliest possible starting date and your salary expectations.

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Zuletzt aktualisiert am 19.04.2024