Descrizione:
Experteer Overview
In this role you will coordinate training and documentation across the Global TechOps & Supply area to ensure GMP compliance and effective knowledge management. You will contribute to governance and implementation of the new document management system, align training with regulatory requirements, and support audits and KPI tracking. You’ll collaborate with Parma Plant personnel and cross-functional teams to improve TechOps processes. This position offers a meaningful impact on manufacturing quality and compliance within a global biologics/pharma setting.
Retribuzione / Benefits
- Analyze and collect GMP-related training needs for Parma Plant personnel
- Organize GMP courses for TechOps staff, in-house or with external consultants
- Issue the TechOps training program and prepare annual reports
- Participate in the governance team for the training management system to stay compliant
- Support projects aimed at improving TechOps training processes
- Manage documentation system per company guidelines and GMP/regulatory requirements
- Participate in governance for the current document management system
- Join the project team for implementing a new document management system
- Supervise and assist the TechOps QA archive management
- Provide support during Corporate Quality audits and regulatory/customer audits
- Evaluate and authorize access to computerized systems in TechOps
- Monitor training and documentation KPIs
Responsabilità
- Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
- At least 5 years of experience in pharmaceutical/biopharmaceutical manufacturing, specifically in QA, Production, and Process Technology
- Excellent knowledge of EU and FDA pharmaceutical guidelines
- Specialized expertise in GMP compliance improvement processes
- Fluent English (written and spoken)
Requisiti fondamentali
- comprehensive healthcare programs
- work-life balance initiatives
- relocation support
- flexible working arrangements
- remote work options
- tax assistance for foreign colleagues
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