Starszy Specjalista / Starsza Specjalistka ds. Systemów Jakościowo-Produkcyjnych

Polpharma S.A. is a leading pharmaceutical company operating on international markets, focusing on health care. The role supports the Digital Quality and Production Solutions team in maintaining, developing, and implementing systems supporting quality, production, documentation, registration, and training processes.

• Higher technical education, preferably in computer science, software engineering, automation, information systems, or related fields.
• Minimum 5 years of experience in IT system maintenance, administration, or development.
• Experience in administration and development of electronic document management systems, quality systems, or business process support applications.
• Ability to create and develop low-code applications, workflows, forms, and system integrations.
• Knowledge of relational databases and SQL, especially MS SQL or Oracle SQL.
• Knowledge of at least one programming language, preferably C# or Python.
• Ability to define business and technical requirements and translate user needs into digital solutions.
• Ability to analyze technical and process problems and propose effective solutions.
• Experience collaborating with business users, vendors, and project teams.
• Independence, very good work organization, and developed communication skills.
• English proficiency enabling cooperation with vendors and working with technical documentation.

Nice to have:

• Knowledge of eDMS, DMS, QMS, RIM, LMS or other systems supporting quality, regulatory, and training documentation.
• Experience in creating applications on low-code platforms, especially WEBCON or similar.
• Familiarity with technologies and tools such as Documentum, DocuBridge, IIS, SharePoint, Jira, Azure DevOps, or Splunk.
• Experience integrating systems using APIs and automating processes with scripts, services, or RPA tools.
• Knowledge of computerized system validation (CSV), Data Integrity, and EU GMP Annex 11 requirements.
• Experience working in the pharmaceutical, production, or other regulated environments.
• Knowledge of Business Intelligence tools like Power BI.
• Understanding of registration documentation structure and XML formats.
• Experience with tools like Jira, Azure DevOps or similar.
• Ability to use AI tools in daily work, create effective prompts, and automate business processes.

• Implement, maintain, and develop systems supporting quality, production, documentation, registration, and training processes.
• Serve as technical owner of assigned solutions and collaborate with vendors and Digital/IT teams.
• Design and develop electronic document workflows, profiles, templates, workflows, and user portals.
• Create and develop low-code applications supporting Industrial Operations, Quality, and Regulatory Affairs processes.
• Define and agree on business, functional, and technical requirements for new solutions and changes.
• Collaborate on integration design, automation, and data exchange solutions between systems.
• Coordinate cooperation between quality, production, registration, validation areas, IT/Digital teams, and external vendors.
• Co-create and update technical, operational, project, and validation documentation.
• Ensure solutions comply with GxP and EU GMP Annex 11 requirements.
• Handle system incident reports, analyze problems, and coordinate corrective actions with vendors.
• Monitor system performance and initiate improvement, standardization, and automation activities.
• Manage vendor cooperation, monitor work execution, and accept results per business requirements.
• Support the organization in digitalization and AI-based solution usage in processes.

Application process data privacy information and GDPR compliance details provided by Polpharma S.A.