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Posted 3 days ago

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Junior Serialization & Laboratory Software Platforms Administrator

AthensOn-siteFull-time

AI Summary

The Junior Serialization & Laboratory Software Platforms Administrator is an entry-level role within the IT Department of a leading pharmaceutical company. Under the guidance and supervision of senior team members, the role holder will learn, support, and progressively assume ownership of the company's Serialization ecosystem (Levels 3, 4 & 5) and Laboratory Equipment Software platforms.

About this role

The Junior Serialization & Laboratory Software Platforms Administrator is an entry-level role within the IT Department of a leading pharmaceutical company. Under the guidance and supervision of senior team members, the role holder will learn, support, and progressively assume ownership of the company's Serialization ecosystem (Levels 3, 4 & 5) and Laboratory Equipment Software platforms. The role contributes to product traceability, authenticity, and patient safety in accordance with the EU Falsified Medicines Directive (FMD), GS1 Global Serialization standards, and EU GMP Annex 11 requirements for computerised systems.

Key Responsibilities

A. Serialization System Support (Levels 3, 4 & 5)

  • Assist in the day-to-day operation and support of the company’s Serialization system across Level 3 (Site-level), Level 4 (Enterprise-level), and Level 5 (Network/Regulatory), under the guidance of senior team members.
  • Support the traceability and authenticity processes of the end product throughout the pharmaceutical supply chain, in alignment with the EU Falsified Medicines Directive (EU FMD 2011/62/EU) and Delegated Regulation (EU) 2016/161.
  • Assist in creating, configuring, and maintaining serialized products in the Level 4 (Unitrace) and Level 3 (Guardian) environments, including GTIN management, serial number (SN) pool allocation, and product master data maintenance.
  • Monitor and escalate issues, alerts, and anomalies associated with the serialization process raised by the European Medicines Verification Organisation (EMVO) and/or National Medicines Verification Organisations (NMVOs), supporting the investigation and resolution of decommission requests and SN status verifications.
  • Support Contract Manufacturing Organisation (CMO) projects with pharmaceutical partners, assisting with onboarding activities, system interconnection tasks, and handling of relevant serialization process activities under supervision.
  • Assist in managing MAH (Marketing Authorisation Holder) connections, coordinating with In-licensing, Business Development, Packaging Engineers, and Regulatory Affairs for new product serialization setup.
  • Verify SN availability for packaging lines and assist in confirming serialized batch statuses prior to and during production runs.
  • Help maintain serialization master data in shared repositories and coordinate with Packaging Engineers and Serialization Engineers (Technical Department) for product data accuracy.
  • B. Laboratory Equipment Software Platforms Support
  • Assist in the operation and support of Laboratory Equipment Software platforms, primarily Agilent OpenLab CDS and Waters Empower CDS and various other laboratory software platforms, supporting the proper operation of Quality Control and R&D Laboratories across all company sites.
  • Support user lifecycle management for laboratory applications: user creation, modification, role assignment, deactivation, and account unlocking for QC and R&D users across multiple sites.
  • Perform client installations of OpenLab and Empower on users’ workstations and assist with software/system upgrades and patches.
  • Troubleshoot and resolve basic software/system issues, reviewing error logs, conducting initial investigations, and escalating to senior administrators or external vendor support (Agilent, Waters, etc.) when required.
  • Assist in ensuring access control to laboratory instruments is properly maintained and compliant with EU GMP Annex 11 principles of identity and access management, audit trails, and data integrity (ALCOA+).
  • C. GxP Compliance & Validation Support
  • Learn and apply EU GMP Annex 11 (Computerised Systems) requirements, including validation, data integrity, access control, change control, audit trails, electronic signatures, backup & recovery, and periodic review.
  • Assist in Operational/Performance Qualification (OQ/PQ) activities for laboratory systems, including protocol execution, test documentation, and evidence gathering.
  • Support Installation Qualification (IQ) activities for new laboratory system implementations under senior guidance.
  • Participate in Change Control processes for all administered platforms, assisting with documentation, impact assessment, and QA coordination.
  • Perform and verify monthly manual backups for laboratory systems (~37 different systems) and support Business Continuity / Contingency Planning readiness.
  • Assist in creating, reviewing, and revising IT SOPs to ensure alignment with IT processes and GMP requirements.
  • D. Projects & Continuous Improvement.
  • Participate in implementation projects for new laboratory systems and serialization enhancements, supporting URS creation, vendor coordination, and project management for IT and infrastructure needs.
  • Proactively identify improvement opportunities in daily operations and propose solutions to the senior team.
  • Serve as a supporting IT contact for QC, R&D, Biotech, Pharmacovigilance, and Regulatory Affairs departments for laboratory and serialization software matters.

Requirements

  • University degree in Electrical/Electronic/Computer Engineering, Information Technology, Computer Science, or related discipline.
  • 0–2 years of relevant experience; fresh graduates with strong academic background and relevant internships/thesis projects are encouraged to apply.
  • Solid foundation in IT infrastructure (networking, Windows Server, databases); comfortable with troubleshooting and learning new platforms.
  • Good communication and documentation writing skills in both Greek and English.
  • Basic understanding of pharmaceutical serialization concepts (L1–L5 architecture), EU FMD, and GS1 standards or exposure to serialization platforms (such as Systech, TraceLink, or SAP ATTP) is an advantage.
  • Exposure to laboratory environments and associated instrumentation, esp. Chromatography Data Systems (CDS) or laboratory informatics is a plus.
  • Basic awareness of EU GMP Annex 11, data integrity principles (ALCOA+), and Computer System Validation (CSV) concepts is a plus; or willingness to pursue relevant training.
  • Detail-oriented and organised — able to follow established procedures with precision and consistency.
  • Analytical mindset — strong problem-solving aptitude and logical troubleshooting approach.
  • Team player — able to work collaboratively within the IT team and liaise effectively with QC, R&D, Packaging, QA, and other departments.
  • Proactive and responsive — able to take initiative, escalate appropriately, and follow through on assigned tasks.

Benefits

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

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