We are looking for a motivated and committed IMP Quality Clinical Packaging for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 18 month assignment.
IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products (“IMPs”) to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all. We are committed to transform ourselves from the inside out towards a purpose driven organization based on strength and role based working. We do this in order to create a great place to work, so each of us can thrive and to unleash our full potential.
Tasks andResponsibilities
* Support all quality-relevant packaging processes and collaborate with packaging operations and all relevant interfaces with regard to GMP topics
* Partner with stakeholders and provide GMP support to ensure successful delivery of the company goals
* Review and release of manufacturing specifications and Batch Records (BR) of finished and semi-finished goods
* Manage actively Deviations and Changes
* Collaboration through to the management of local and global projects
* Actively engage in optimization activities and improvements within IMP Quality Clinical Packaging Switzerland. Coordinatenimprovement projects and engage in corrective and preventive measures (CAPA)
* Build, verify and implement standard documents (SOPs)
* Joy in a human-centered and self-managed way of working based on NewWork, with a key focus to support the ongoing cultural and organizational change towards collaboration, agility and innovation mindset
Must Haves
* Min. Master Degree preferably in Life Sciences or Engineering or similar degree
* Min. 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 the area of pharmaceutical development such as packaging lines or materials, master data management, quality control or quality assurance is an advantage
* Proven track record to work towards outcomes and an innovative manner of solving problems
* Strong team-player with a high level of self-motivation and being able to inspire others
* Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness
* Ability to communicate clearly and professionally verbally and in writing in BOTH German and in English is a must.
* Experience with SAP and Veeva is a plus
Are you interested? Don't hesitate and send us your complete application documents online today.
We will also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!
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