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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.