Clinical Quality Specialist
Vor 2 Tagen
We are seeking a highly motivated and committed Clinical Quality Specialist to join our team at TN Switzerland for an 18-month assignment. As a Clinical Quality Specialist, you will be responsible for delivering Investigational Medicinal Products (IMPs) to patients in compliance with cGMP. You will work closely with packaging operations and relevant interfaces to ensure successful delivery of company goals.
Key Responsibilities:
- Support quality-relevant packaging processes and collaborate with stakeholders.
- Partner with stakeholders to ensure GMP support and 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.
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