Job Summary
The resource supports the end-to-end rollout of a Laboratory Information Management System (LIMS) within the pharmaceutical Quality Control (QC) and Quality Assurance (QA) environment. This is a junior role designed to build capability in program planning and control, contributing to delivery against agreed scope, schedule, cost, and quality requirements, and supporting cross-functional coordination across QC, QA, IT, CSV, vendors, and other stakeholders under the guidance of the Program/Project Manager.
What You’ll Do
* Support the Program/Project Manager in planning and executing a LIMS rollout program across one or more sites.
* Create, maintain, and update integrated project plans (work breakdown structure, milestones, dependencies) and contribute to program governance materials (status decks, RAID logs, minutes, actions).
* Monitor and report progress against schedule, cost, and resource plans; track activities, deliverables, and critical path items.
* Support cost tracking, forecasting, and overall project budget verification; highlight variances, risks, and required corrective actions.
* Support coordination of internal and external resources (QC, QA, IT, CSV, vendors) to ensure timely completion of tasks and resolution of issues.
* Maintain and update RAID (Risks, Assumptions, Issues, Dependencies) and change control items; ensure decisions and actions are documented and followed up.
* Support preparation and facilitation of project meetings, workshops, and steering/working group sessions; ensure clear communication and follow-through.
* Contribute to quality and compliance activities related to computerized systems implementation (e.g., documentation readiness, traceability, review workflows).
Qualifications and Need-to-Know
* Solid understanding of pharmaceutical Quality Control laboratory workflows (e.g., sample management, testing execution, data review/approval, OOS/OOT support interfaces) and related documentation practices.
* Understanding of LIMS concepts and core functionalities (e.g., sample lifecycle, test assignment, results entry, calculations, specifications/limits, instruments/interfaces, reporting, audit trails).
* Knowledge of quality approaches for computerized systems implementation in regulated environments, including documentation discipline, traceability, and quality-by-design principles for system configuration and deployment.
* Experience contributing to project planning and control activities: building project plans, tracking tasks and milestones, and managing dependencies.
* Ability to monitor and consolidate project data for schedule, costs, resources, and budget tracking, ensuring accuracy and timely escalation of deviations.
* Strong communication skills, with the ability to translate complex project information into clear updates for different audiences.
* Proven ability to coordinate cross-functional teams and drive action follow-up in a structured, collaborative way.
* Organized, detail-oriented, and proactive; able to manage multiple priorities under tight timelines.
* Comfortable working with stakeholders at different levels, including laboratory users, QA, IT, and external vendors.
* Degree in Life Sciences, Chemistry, Pharmacy, Engineering, Computer Science, or equivalent experience.
* 0–2 years of experience in project coordination/program support roles, preferably within pharma/biotech or regulated laboratory environments (internship/thesis/project work considered).
* Proficiency with common project tools (e.g., MS Project or equivalent planning tools; Excel; PowerPoint); ability to build structured trackers and dashboards.
* Fluent English (spoken and written) required; Italian is a plus.
Preferred (Nice to Have)
* Hands‑on exposure to LIMS implementation projects (requirements, configuration, testing, data migration, deployment, hypercare).
* Familiarity with CSV/validation lifecycle concepts and deliverables in regulated environments.
* Experience working with laboratory instruments/interfaces and data integrity topics.
* Knowledge of change management and training coordination for laboratory end users.
This announcement is addressed to applicants of both sexes (L. 903/77 - D.Lgs n. 198/2006) and also to those belonging to Protected Categories (L.68/99).
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