Técnico Nuevos Productos
Hace 24 horas
a coruña, kingdom of spain
3001 ROVI PHARMA INDUSTRIAL SERVICES, S.A.U.
Jornada completa
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What do we do?
We are a Spanish pharmaceutical company engaged in the research and development, manufacturing and marketing of small molecules and biological medical products. We likewise use our sales channels to market a number of licensed pharmaceutical products, imaging contrast agents and other products for hospital use, as well as OTC pharmaceuticals. All of this is carried out through our specialized sales team formed by more than 260 people who promote the products with specialized medical professionals and in hospitals and pharmacies.
What will you do? 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
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.
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.
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) Risk Analyses Process and Cleaning Validation Protocols (PVP) Stability Plans, Specifications, and Artworks. Ensure all project documentation meets regulatory and company standards.
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.
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.
Contract Type
PermanentRequired Education
Bachelors Degree: PharmacyExperience
From 3 to 5 years
We are a Spanish pharmaceutical company engaged in the research and development, manufacturing and marketing of small molecules and biological medical products. We likewise use our sales channels to market a number of licensed pharmaceutical products, imaging contrast agents and other products for hospital use, as well as OTC pharmaceuticals. All of this is carried out through our specialized sales team formed by more than 260 people who promote the products with specialized medical professionals and in hospitals and pharmacies.
What will you do? 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
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.
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.
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) Risk Analyses Process and Cleaning Validation Protocols (PVP) Stability Plans, Specifications, and Artworks. Ensure all project documentation meets regulatory and company standards.
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.
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.
Contract Type
PermanentRequired Education
Bachelors Degree: PharmacyExperience
From 3 to 5 years