Job Title: IMP Quality Clinical Packaging (m/f/d)
Location:
Kaiseraugst
Job Responsibilities:
We are seeking a highly skilled and motivated individual to join our team as an IMP Quality Clinical Packaging professional. The successful candidate will be responsible for ensuring the quality of Investigational Medicinal Products (IMPs) delivered to patients in compliance with current Good Manufacturing Practice (cGMP) regulations.
The role requires a high level of flexibility, ability to work under pressure, and sense of responsibility. You will support end-to-end cGMP activities, maintain the Right to Operate at the Clinical Packaging Site in Kaiseraugst, and ensure the quality of IMP products to meet Health Authority requirements and Company Standards.
Tasks & Responsibilities:
1. Support all quality-relevant packaging processes and collaborate with packaging operations and relevant interfaces on GMP topics.
2. Partner with stakeholders to ensure successful delivery of company goals, providing GMP support as needed.
3. Review and release manufacturing specifications and Batch Records (BR) of finished and semi-finished goods.
4. Manage deviations and changes actively.
5. Collaborate on local and global projects through to their management.
6. Engage in optimization activities and improvements within IMP Quality Clinical Packaging Switzerland, coordinating improvement projects and implementing corrective and preventive measures (CAPA).
7. Build, verify, and implement standard documents (SOPs).
8. Embody a human-centered and self-managed way of working based on NewWork, focusing on supporting cultural and organizational change towards collaboration, agility, and innovation.
Requirements:
* Master's degree in Life Sciences or Engineering or similar field.
* At least 3 years of experience in the pharmaceutical industry in a quality manager role.
* Knowledge of cGMP and quality requirements for clinical development phases.
* Experience in pharmaceutical development, such as packaging lines or materials, master data management, quality control or quality assurance, is advantageous.
* Proven track record of working towards outcomes and innovative problem-solving methods.
* Strong team-player with high self-motivation and ability to inspire others.
* Ability to work in a purpose-driven organization, taking full ownership of assigned roles and tasks, and continuously improving individual and team effectiveness.
* Proficiency in communicating clearly and professionally in both German and English.
* Experience with SAP and Veeva is a plus.