Giuseppina Picozzi, (PMP)®

Experience

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  Janssen, Pharmaceutical Companies of Johnson and Johnson

  May 2008 - Dec 2008

  Quality Control analyst

  Execute quantitative and qualitative analysis on Stent (medical device)Manage changes control and laboratory investigationsReview and update analytical methods and specifications Execute lab instruments decommissioning

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  Abbott s.r.l.

  May 2009 - Feb 2012

  Quality Assurance Officer

   Write quality reports about production and laboratories Not conformities / deviation, applying CAPA.Execute IQ-OQ-PQ and Cleaning of Facilities, Utilities ed Equipment Manage Validation Change Request (VCR) and write Validation Master Plan (VMP)Support Supplier qualificationRedazione di Product Quality ReviewRewiew executed Batch Record Support AIFA, FDA and corporate inspections

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  Thermo Fisher Scientific

  Apr 2012 - Feb 2018

  Project Manager

  -Managing formulation and process development scale up to GMP activities and CTM (biologics & standard small molecules)- Managing CMO operations for clinical Phase I, II, III and small scale commercial- Facilitate positive team member interactions and manage conflicts- Handling multiple clients requests in the expected timeline with high quality results- Handling project activities multifunctional team both internal and external to PDS- Risk management and back-up plan building intra and inter projects- Deliver projects on time and within budget, addressing issues/risks and finding resolutions- Give assistance in managing client satisfaction and mitigate client temperature concerning project risks and issues- Summarizes progress of the projects by routinely communication to upper management- Handling client's meeting- Writing the minutes of the meetings/telecon- Archive the any project documentation and communication - Update and maintain projects on Changepoint platform-Drafting of the Changes of Scopes to support costs projects- Supporting Finance for projects billings- Give assistance with importation of API and shipment of finish product- Lead or support new initiatives, including the promotion of continuous improvement in business,- operational and GMP processes within site DPX program- Lead or support departmental or site projects as required- Commercial/PDS Interface: Working with PDS and Commercial Management to support the efficient scheduling of PDS project activities. Show less

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  Olon SpA

  Feb 2018 - Sept 2022

  Technology Transfer Project Manager presso Capua BioServices – part of Olon SpA

   Ensuring that technical information acquired from customer is received and processed by the site Driving tech transfer interdisciplinary groups, assigning and coordinating the tasks related to the introduction of new processes/projects within the site Generating key documentation (URS, Technology Transfer plan Gap Analyses, Risk Management, Action and Decision logs, Project plan, meeting minutes, Technology Transfer report,) with the support of the project team Managing and controlling the progress of the project, by identification of technical risks and responses supported by the specialists of the involved functions and by using the following tools (proposals, scope changes, kick-off, escalation, billing, dashboard, costs tracking) Communicating and negotiating activities with a large number of stakeholders (internal and external) to fit project objectives Be accountable for delivering product in alignment with the program strategy of the client and within the budget Supporting Account Manager to address any technical scope change Supporting Finance Dept for project billings Controlling the investments plans related to the project Verifying the production schedule vs Sales demand planning Show less

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  GSK

  Sept 2022 - now

   Accountable end-to-end for an investment project or a portfolio of projects from Feasibility to Handover, in line with the approved scope, schedule, budget, resources and quality standards.  Prepare and Submit “Project Investment Proposal” in cooperation with Capital Plan Manager and collecting requirements from departments (Manufacturing, Quality, HSE); ensure adequate sponsorship during approval process. Design and execute strategic investment projects according to Safety and Global Engineering Standards and Site Master Plan.  Drive all the investment project phases: feasibility, submission, design, construction, commissioning, validation and handover. Strongly apply project management methodologies with focus on risks identification & mitigation, driving problem solving sessions and structured “after action review”, HSE review and GMP review at sub-sequential stage gates Establish appropriate project governance; leads project Steerco meeting, keeping Steering groups and Sponsor informed of project achievements / risks and critical issues that could jeopardize project success; Decision maker for project re-baseline.  Support GMP and HA inspections either during the preparation phase and as former; when required, collaborate with relevant department to ensure appropriate documentation is available for products Registrations and launches in selected markets. Show less  Accountable end-to-end for a project or a portfolio of projects from Feasibility to Handover; ensuring scope, schedule and costs are agreed and approved; accountable for Project Execution according to HSE standards and adherence to KPIs; strongly apply project management methodologies with focus on risks identification & mitigation, driving problem solving sessions and structured “after action review”. Design the project organization structure, ensuring efficient resource management; lead the project teams & drives project teams capacity management to assure project success; clearly and transparently manage team members low performance with respect to project execution. Strong stakeholder management and negotiation to ensure projects/programs are fully supported by proper resources; define projects connections with the business; navigate the organization at different level driving prompt, clear and proactive communication to ensure request of support/ decisions are delivered at right audience; interact with Global Leadership Team either as SPOC for the project or as supportive member.  Establish appropriate project governance; leads project Steerco meeting, keeping Steering groups and Sponsor informed of project achievements / risks and critical issues that could jeopardize project success; Decision maker for project re-baseline.  Support GMP and HA inspections either during the preparation phase and as former; when required, collaborate with relevant department to ensure appropriate documentation is available for products Registrations and launches in selected markets. Show less

  • Project Delivery Manager

    Apr 2024 - now

  • PMO Project Lead

    Sept 2022 - Apr 2024