New Products Introduction Specialist (Project Manager)

ROIS; San Sebastián de los Reyes; Presencial; EUR 60 000 - 85 000; Tempo integral

Resumo da oferta

ROIS is seeking a New Products Introduction Project Manager to plan and coordinate technology transfer and product variation projects in a pharmaceutical manufacturing environment. You will ensure timely delivery, budget control, and regulatory compliance while facilitating collaboration between clients and internal departments.

The role requires organizing project plans, coordinating cross-functional teams, and managing documentation such as CC, URS, QA, AMT, PVP, and stability workstreams.

Qualificações

• Experience in technology transfer and project management within the pharmaceutical industry.
• Familiarity with regulatory documentation and compliance standards.
• Strong organizational, communication, and problem-solving skills.
• Ability to coordinate and manage cross-functional teams effectively.

Responsabilidades

• Develop the Technology Transfer Plan and/or Change Control documentation, including project budgets, timelines, and team structures.
• Draft and circulate plans for review, feedback, and approval.
• Create and maintain a comprehensive project schedule with activities, responsibilities, and deadlines.
• Manage project execution to meet established goals for deliverables, timelines, and budgets.
• Identify project stakeholders and ensure effective communication of client requirements to the manufacturing plant.
• Schedule and coordinate necessary meetings, teleconferences, and updates.
• Act as a liaison between departments and clients, fostering collaboration and resolving issues.
• Coordinate and contribute to the preparation of key documents, including: Change Controls (CC), User Requirement Specifications (URS), Quality Agreements (QA), Analytical Transfer Protocols (AMT), Process and Cleaning Validation Protocols (PVP), Stability Plans, Specifications, and Artworks.
• Ensure all project documentation meets regulatory and company standards.
• Track project progress, identify potential risks, and implement solutions to mitigate delays or issues.
• Support investigations and problem-solving throughout the project.
• Manage project budgets and expenses, providing updates as needed.
• Finalize all required documentation and reports for project completion (e.g., TTP Report).
• Communicate the completion of billable activities to relevant stakeholders.
• Provide support and expertise for other projects when needed.

Descrição da oferta de emprego

The New Products Introduction Project Manager is responsible for planning, coordinating, and executing technology transfer and product variation projects within the pharmaceutical manufacturing environment.

This role ensures successful delivery of project objectives, including timelines, budgets, and regulatory compliance, while facilitating collaboration between clients and internal departments.

Key Responsibilities:

1.Project Planning and Documentation:

• Develop the Technology Transfer Plan and/or Change Control documentation, including project budgets, timelines, and team structures.
• Draft and circulate plans for review, feedback, and approval.
• Create and maintain a comprehensive project schedule with activities, responsibilities, and deadlines.

2.Project Coordination:

• Manage project execution to meet established goals for deliverables, timelines, and budgets.
• Identify project stakeholders and ensure effective communication of client requirements to the manufacturing plant.
• Schedule and coordinate necessary meetings, teleconferences, and updates.
• Act as a liaison between departments and clients, fostering collaboration and resolving issues.

3.Documentation Management:

• Coordinate and contribute to the preparation of key documents, including:
• Change Controls (CC)
• User Requirement Specifications (URS)
• Quality Agreements (QA)
• Analytical Transfer Protocols (AMT)
• Process and Cleaning Validation Protocols (PVP)
• Stability Plans, Specifications, and Artworks
• Ensure all project documentation meets regulatory and company standards.

4.Monitoring and Risk Management:

• Track project progress, identify potential risks, and implement solutions to mitigate delays or issues.
• Support investigations and problem-solving throughout the project.
• Manage project budgets and expenses, providing updates as needed.

5.Project Closure:

• Finalize all required documentation and reports for project completion (e.g., TTP Report).
• Communicate the completion of billable activities to relevant stakeholders.

Additional Duties:

• Provide support and expertise for other projects when needed.

Requirements:

• Experience in technology transfer and project management within the pharmaceutical industry.
• Familiarity with regulatory documentation and compliance standards.
• Strong organizational, communication, and problem-solving skills.
• Ability to coordinate and manage cross-functional teams effectively.