Serialization Process Specialist

PharmaPath, a Greek pharmaceutical company with a rich history and significant legacy in the pharmaceutical field of generic medicines, is seeking a dedicated and skilled Serialization Process Specialist to join our dynamic team. 

Main duties and responsibilities:

• Onboard new partners for exchange of serialization information, ensuring interfaces between systems are maintained and validated according to PharmaPath policies and procedures
• Maintain procedures and compliance with serialization regulations in a timely manner
• Proactively monitor the systems daily to avoid delaying product release to market
• Create formats, layouts and products in Level 2 and Level 3 software, to ensure smooth operations. Managing & maintaining Level 4 connections to ensure uninterrupted supply chain operation
• Assist in investigating and verifying negative responses/complaints to saleable return verification requests
• Manage change controls and deviations associated with Serialization as well as issuing CAPAs as required
• Troubleshoot serialization related issues. Formal investigation of support issues, communication with impacted stakeholders, vendors, resolution/closure of the issue, and updating appropriate knowledge management records
• Identify any gaps and suggest improvements based on industry best practices
• Evaluation and development of SOPs to ensure compliance with current and future EMVO requirements
• Manage master data to ensure accurate data exchange with upstream and downstream trading partners
• Development of Design Qualification, Functional Requirements, User Requirements, validation plans, validation summary report, traceability matrix, IQ/OQ/PQ
• Audit trail and data review of production systems, with the understanding of 21 CFR PART 11
• Contribute to the definition of the future technology roadmap by identifying value adding technology opportunities and support the implementation of e-batch records project

Requirements:

• Bachelor’s degree (BSc) in Computer Science, Engineering, or a related discipline.
• A minimum of 2 years of hands-on experience in serialization processes, specifically within the pharmaceutical sector
• Practical knowledge or familiarity with Antares serialization systems and the TraceLink platform is highly desirable
• Comprehensive understanding of Global Serialization Standards (GS1), including regulatory requirements and guidelines across international markets
• Effective communication skills to liaise with technical teams, suppliers, and regulatory bodies
• Team-oriented approach with the ability to work independently under minimal supervision
• Excellent knowledge and handling of both verbal and written English language

Benefits:

• Competitive remuneration package, including benefits
• Ability to become part of one of the most dynamic and prospective teams in the Pharmaceutical industry in Greece
• Continuous opportunities in advancing personal and career goals