**MISSION**
Responsible to coordinate the projects assigned related to the introduction of new products, processes and technologies into production as well as life cycle management, monitors the changes in existing products and processes, making sure that new products make a smooth transition from trial and testing stages to full production; leads the projects assigned related to equipment/technologies introduction, ensuring high level of applicable standards as well as that the validation status of processes is maintained, according to the leader above and in alignment with QMS, safety, regulatory requirements, customer expectations, working alongside the other functions involved such as R&D, Quality, Engineering and the others Operations Teams.
**KEY ACCOUNTABILITIES
**1.
DESIGN AND TECHNOLOGY TRANSFER MANAGEMENT**
- Coordinates the project team assigned in order to facilitate the introduction of new processes, equipment and products through to successful production launch, conducting feasibility studies in order to ensure product consistency in the most efficient way for the relevant area.
- Proposes, designs and introduces improved technological solutions to maximize the efficiency of process, leading risk assessments, reports any potential critical issues and deals with troubleshooting of technical product issue, deviations management and change control, working with the other functions involved.
- Elaborates all the technical transfer documents, quality attributes, including critical quality attributes, process capabilities gap and the relevant critical parameters, working with R&D, Quality and Productions Teams, providing input in the early development phase to ensure the timely and efficient process implementation at manufacturing scale and vice versa.
- Set up plans in accordance with the leader above and achieves agreed milestones and targets, provides the involved functions with inputs with the aim of sustain a feasible transition to production and minimization of costs, contributing to lifecycle management project, ensuring compliance to all relevant quality standards and regulatory requirements.
**2.
EQUIPMENT AND NEW TECHNOLOGY MANAGEMENT**
- Enables the user requirement collection phases during the new/revised equipment concepts, ensuring documents and reports required for the investment proposal, working closely with the other functions involved in order to provide all the requirements and analysis needed for the project assigned.
- Enables innovation, coordinating and monitoring the project assigned related to the introduction of new technologies, infrastructure change and expansions (if applicable), processes and information systems as appropriate to address the changing environment, deals with the relevant testing processes (i.e FAT, SAT) and qualification processes, working with the other external and internal stakeholders involved, enhances existing operations, striving toward excellence.
- Participates in cross functional teams to establish validation plan and objectives to support process and equipment changes, maintaining process validation status, ensuring all the relevant documentation required (operating procedures, protocols, specifications etc.
), working alongside Validation Team and the other functions involved.
**3.
MONITORING AND REPORTING**
- Monitors the operation KPI's dashboard, highlights critical issues and proposes actions aimed at solving it to the leader above, working alongside the other involved functions, ensuring an efficient and effective operatively execution within the relevant area.
- Coordinates the timely compilation of the relevant reports and documents (i.e deviations, change requests etc.)
and monitors the progression for assigned projects in term of timing, performances, outcomes delivery, managing recovery plans execution in order to ensure the results expected within the agreed timescales.
**4.
STANDARD, GUIDELINE AND PROCEDURES MANAGEMENT**
- Cascades to the project team assigned the relevant procedures, guidelines and other documents, ensuring best practice alignment within the site/area and driving the operatively implementation across the functions involved in order to maintain high level of applicable standards.
- Maintains an ongoing understanding of the latest regulatory requirements for validation, in order to ensure the compliance to the applicable standards, working alongside with the others Quality teams.
**5.
PROJECT MANAGEMENT**
- Leads the projects of the assigned area, coordinating project team in alignment with priorities and activities planned with the aim of ensuring timely and consistent project targets achievement.
- Presents to the Leader above in-depth analysis and reports in order to facilitate decision-making process on critical points by evaluating different project scenarios and their impacts.
**6.
RELATIONSHIP MANAGEMENT**
- Coordinate the resources and the project managers assigned to his area
- Deals with the exter