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Principal Packaging Engineer
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Principal Packaging Engineer
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
Packaging Operations Manager
vor 2 Wochen
TN Switzerland is seeking a Regulatory Affairs Professional for an 18-month assignment. As a Regulatory Affairs Professional, you will be responsible for ensuring that TN Switzerland complies with regulatory requirements for the delivery of Investigational Medicinal Products (IMPs). You will work closely with packaging operations and relevant interfaces to ensure successful delivery of company goals.
Key Responsibilities:
- Ensure compliance with regulatory requirements for the delivery of IMPs.
- Collaborate with packaging operations and relevant interfaces to ensure successful delivery of company goals.
- Review and release manufacturing specifications and Batch Records (BR) of finished and semi-finished goods.
- Manage deviations and changes actively.
- Collaborate through project management and engage in optimization activities and improvements.
- Build, verify, and implement standard documents (SOPs).
Required Skills and Qualifications:
- Master's degree in Life Sciences or Engineering or similar degree.
- Minimum 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 an advantage.
- Proven track record of working towards outcomes and innovative problem-solving.
- Strong team player with high self-motivation and ability to inspire others.
- Ability to communicate clearly and professionally verbally and in writing in both German and English.
- Experience with SAP and Veeva is a plus.
Are you interested? We look forward to hearing from you.