Warsaw, POL
4 days ago
Commercial Quality Specialist
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Customer/Commercial Quality **Job Category:** Professional **All Job Posting Locations:** Warsaw, Masovian, Poland **Job Description:** For J&J Innovative Medicine we are looking for a **Commercial Quality Specialist (CQS)** reporting to Quality Head Poland and to be hired with a fixed-term contract (until April 2026). **Essential Duties and Responsibilities** + Perform tasks according to quality system standards and procedures for distribution, storage, and transportation of medicinal products (GDP). + Participate in Quality Management System processes, including Change Control, Corrective and Preventive Actions (CAPA), deviations, complaints, and documentation management. + Oversee GxP documentation, including updates, distribution, archiving, and compliance analysis. + Participate in internal audits. + Investigate quality problems, conducting risk and root cause analyses. + Participate in supplier qualification processes. + Conduct staff training on the Quality Management System and GxP requirements. + Engage in quality development projects and review quality procedures/instructions. + Collaborate with internal and external partners. + In the absence of Responsible Person for Controlled Substances: - Manage end-to-end import licenses and quality oversight for controlled substances. - Ensure documentation related to controlled substances distribution is implemented and updated. **Activities Requiring Physical Presence at Distribution Center** + Act in the absence of the Responsible Person or Responsible Person for Controlled Substances as per delegated duties. + Finalize product releases for distribution based on inbound documentation. + Handle complaints & returns in collaboration with Customer Service. + Collaborate with Logistics Operator on daily basis. **Requirements** + **Education:** Must be a pharmacist. + **Experience:** Minimum of 2 years of experience working in a pharmacy or pharmaceutical wholesale. + **Language Skills:** English (good knwoledge), fluent in Polish.
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