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For our international pharma client, we are looking for a IMP Quality Clinical Packaging (m/f/d).
IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products (“IMPs”) to patients in compliance with cGMP. We serve as the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland, overseeing quality and compliance. We are committed to transforming into a purpose-driven organization that fosters strength and role-based working, creating a great workplace where everyone can thrive and reach their full potential.
The perfect candidate:
This role requires flexibility, the ability to work under pressure, and a strong sense of responsibility. You should be inspiring, self-reflective, and creative, with clear communication skills and an integrative approach to solutions. 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 meets health authority requirements and company standards. You will be designated as the delegate of the Swiss Responsible Person for IMPs ('Fachtechnisch verantwortliche Person, FvP'), responsible for lot disposition and certification of finished IMP products.
General Information:
• Planned duration: 12 months (max till end May)
Tasks & Responsibilities:
* Support quality-relevant packaging processes and collaborate with packaging operations and other interfaces regarding GMP topics
* Partner with stakeholders and provide GMP support 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 proactively
* Participate in local and global project management
* Engage in optimization activities and improvements within IMP Quality Clinical Packaging Switzerland, including CAPA
* Develop, verify, and implement standard documents (SOPs)
* Support a human-centered, self-managed working environment based on NewWork principles, fostering collaboration, agility, and innovation
Must Haves:
* Master's Degree in Life Sciences, Engineering, or similar
* At least 3 years of experience in pharmaceutical quality management
* Knowledge of cGMP and quality requirements in clinical development
* Experience in pharmaceutical packaging, materials, master data, quality control, or assurance is advantageous
* Proven track record of outcome-oriented and innovative problem solving
* Strong team player, self-motivated, inspiring others
* Ownership mindset, committed to continuous improvement
* Excellent communication skills in German and English, both verbal and written
* Experience with SAP and Veeva is a plus
Deadline: 25.05.2025
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Production
* Industries: Pharmaceutical Manufacturing, Chemical Manufacturing, Biotechnology Research
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