QA Operations Specialist – 6531
We are currently looking for anQA Operations Specialist – 6531 for an initial 1-year contract, with potential extension,to bebased inBasel/Kaiseraugst,Switzerland.
The roles within IMP Quality Operations Switzerland Clinical Packaging Team requests a high level of flexibility, ability to work under pressure and sense of responsibility. You are inspiring, self-reflected and creative on the one hand and are clear in communication as well as integrative in solution processes on the other. You support the end-to-end cGMP activities, maintaining the Right to Operate at the Clinical Packaging Site in Kaiseraugst, ensure the quality of IMP products to meet Health Authority requirements and Company Standards for IMP products.
Main Responsibilities:
·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. Coordinate improvement projects and engage in corrective and preventive measures (CAPA)
·Build, verify and implement standard documents (SOPs)
Qualifications and Experience:
* Relevant Swiss working/residency permit or Swiss/EU-Citizenship required.
·Bachelor’s or Master’s 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
·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
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