We are seeking a motivated and committed IMP Quality Clinical Packaging professional for an 18-month assignment with F. Hoffmann-La Roche Ltd. in Basel.
Key Responsibilities
* Support quality-relevant packaging processes, collaborating with packaging operations and stakeholders to ensure compliance with Good Manufacturing Practice (GMP) regulations.
* Partner with cross-functional teams to provide GMP support and ensure successful delivery of company goals.
* Review and approve manufacturing specifications and batch records for finished and semi-finished goods.
* Manage deviations and changes effectively.
* Collaborate on local and global projects, driving process improvements and implementing corrective actions as needed.
* Actively engage in optimization activities, identifying opportunities for improvement within IMP Quality Clinical Packaging Switzerland.
* Develop and implement standard documents, including SOPs.
* Contribute to a human-centered, self-managed work environment based on NewWork principles, fostering collaboration, agility, and innovation.
Required Qualifications
* Bachelor's or Master's degree in Life Sciences, Engineering, or a related field.
* Minimum 3 years of experience in the pharmaceutical industry, with a focus on quality management.
* Knowledge of cGMP and quality requirements for clinical development phases.
* Experience in pharmaceutical development, such as packaging lines, materials, master data management, quality control, or quality assurance is advantageous.
* Proven track record of delivering results through innovative problem-solving.
* Strong team player with high self-motivation and ability to inspire others.
* Ability to communicate clearly and professionally in both English and German.
* Experience with SAP and Veeva is a plus.