IA Portfolio Development Specialist

Descrizione dell'offerta

Preparing CTD files for new products submission and for export:

Prepare complete module 3, according to local regulation requirements.

Preparing plan for the upcoming CTD according to priorities.

Estimating workload and solve any bottle neck

Preparing CMC file for new products and Generics:

Prepare all technical data (such as composition formula, specs and COA for active and inactive materials and stability data and tables) and put it in MOH format

Prepare stability files for three validation batches of new products.

Prepare shelf-life stability file to get final registration of product

Preparing preliminary technical evaluation and feasibility of manufacturing:

Perform an evaluation for technical files received from zone for new product (manufacturing process, specifications, analysis, analytical method validation and stability)

Create a preliminary cairo site manufacturing process flowchart

Assist in preparing sourcing cases:

Fill up the form

Creation of monthly action plan related to new products launch and development projects. Follow up implementation of monthly actions determined during SPRINT meetings Member in EAGLE Team Member in INSPIRE Team:

Share in the creation of the planning for all projects (local manufacture) managed by inspire

Providing monthly report to the department head Respect of company’s values, code of ethics and social charter

Perform other duties as assigned

Respect of personal data protection charter

Applying the HSE related requirements for the company in all related working procedures

HSE Responsibilities:

Follow the approved HSE policy and requirements

Assure that the risk assessment of any newly transferred product and processes is carried out and assess its impact on the environment

Waste Management according to the approved system

Follow all the statutory legalization concerning Health, Safety, and environmental law

Participate in developing and implementing strategies & policies to reduce energy consumption.

Key “MUST HAVE” competencies, skills & experiences

·  3– 5 years’ experience in QA or R&D
·  Problem solving and Decision making capabilities
·  Analytical skills
·  Excellent knowledge of Microsoft office
·  Good command of English

“Desirable” / compromise experience

·  The flexibility to multitask and handle multiple requests with varying degrees of priority simultaneously.
·  SAP background will be valued. Good knowledge of Microsoft project
·  Project Management Diploma is a plus

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.