Quality Assurance Specialist

vor 4 Wochen

Bern, Bern, Schweiz Randstad Vollzeit

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of Johnson & Johnson work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 120,000 people.

Johnson & Johnson Innovative Medicine is a global pharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.

Main Responsibilities

Contact person for production, development, and quality control and WH for all quality related topics within the scope of responsibilityEnsure the quality of materials for production and supplierEnsure that deliverables assigned to LMM as part of projects are successfully achieved on timeReview and release of batches of purchased materials and conduct their qualificationProcess Change Notifications for purchased materialsSupport Supplier QualificationWH Oversight for review of process documentsSupport the GMP-compliant production of active ingredients and drugs for clinical trials and market launchSupport Product MBR reviewSupport QA oversight for aseptic processingReview and approval of non-conformities, CAPAs, and Effectiveness ChecksEnsure the relevancy and effectiveness of corrective and preventive actionsReview and approval of SOPs, work instructions and risk assessments
LIMS profiles' approval for Materials for ProductionsSAP Set up for Materials for ProductionSupport Quality Operations and Product Quality to ensure GMP readiness for NPI projects Support development and deployment of KPIs and Metrics to support continuous improvement.Support the execution of internal and external inspections and audits

qualifications Who we are looking for Master or Bachelor degree in a LifeSciences disciplineWork experience in a GMP related environment, preferable in Quality is a major plusExcellent problem solving and analytical capabilitiesTeam player and a personality with excellent interpersonal communication skills Capacity to communicate fluently in English, German is a major plus This job based in Bern, Switzerland will initially be limited to 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, inclusive, and collaborative environment, then send us your application today. Or give us a call if you have any questions

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