Senior Portfolio Development Coordinator
Job Description
Senior Portfolio Development Coordinator page is loaded
Senior Portfolio Development Coordinator
locationsCairo time typeVollzeit posted onHeute ausgeschrieben job requisition idR2678429
Job Purpose:
The role is responsible for the technical and administrative management of products transfer projects. This includes new launches, localization, formulation development and toll in products. The role is also responsible for artworks update and follow up process.
KEY RESPONSIBILITIES AND DUTIES:
Prepare CMC file for new products and Generics:
Full responsibility for preparation of CMC file for new products and generics
Prepare all initial technical data (such as composition formula, specs and COA for active and inactive materials and stability data and tables)
Ensure completeness of stability files for three validation batches of new products
Prepare preliminary technical evaluation and feasibility of manufacturing:
Perform preliminary technical evaluation and feasibility for new product (manufacturing process, specifications, analysis, analytical method validation and stability)
Create a preliminary Cairo site manufacturing process flowchart
Sourcing cases:
Complete sourcing cases & contracts
Manage Transfer Projects:
Set up a project plan for each transfer
Participate in the projects (local manufacture) managed by the affiliate business development, as required
Provide all necessary technical and logistics support for the team
Ensure proper alignment of all projects’ stakeholders; finance, DRA, procurement, business unit, plant supply chain, RSO, quality assurance, quality control, production, legal, customer (if applicable)
Create a regular communication channel to ensure all stakeholders are updated of the project progress & obstacles
Ensure fulfilling all regulatory requirements related to transfer projects
Maintain a proper documentation system for all projects
Collaborate with the team for resolution of issues that arise, to mitigate any risk of project completion according to the pre-set timelines
Act as the focal point for artwork management process
Organize monthly SPRINT meeting for governance of all ongoing projects
Report the progress of projects monthly in a clear actionable format
HSE Responsibilities:
Commitment to the appropriate PPE use
Follow the approved HSE policy and requirements
Follow the statutory legislation concerning Health, Safety and environmental law
Waste management according to the approved system
HSE Responsibilities in case joining HSE Excellence team:
Facilitate and guide the employees to implement the HSE&En. Policies.
Implement all applicable standards and guides of Sanofi-Aventis in his/her area
Ensure of complying with all legal and Sanofi-Aventis requirements
Lead his/her team to implement the HSE & EnMS PASS
Train his/her team on HSE & EnMS procedures, SOP’s and MSDS
Report any accidents/incidents in his/her area to the HSE department
Lead his/her team for investigate accidents/incidents to define the root cause
Support the area manager in taking the corrective and preventive actions to eliminate recurrence of any Environmental or Energy nonconformance
Support the area manager in taking the corrective and preventive actions to eliminate recurrence of any accident/incident
Sharing for HSE / EnMS inspection program, take the corrective actions for any violations in his/her area
Lead the team of his/her area for doing full risk assessment and Environmental aspects studies
Define and control the required PPE’s for his/her area
Define the list of CMR and its operational control for Quality labs and production areas
Control the first aid kits in his/her area
Leading his/her team in controlling the significant hazards /aspects and Energy use
Others:
Perform other duties as assigned.
Respect of company’s values, code of ethics and social charter.
Respect of personal data protection charter.
Responsible for applying the HSE related requirements for the company in all related working procedures.
JOB-HOLDER’s ENTRY REQUIREMENTS
:
Education:
B.Sc. of Pharmaceutical science
Related Experience:
5-7 years of related industrial experience
Special Knowledge/Skills:
Excellent communication and presentation skills
Well developed planning and organization skills to manage multiple projects simultaneously
Results-based leadership skills
Ability to function within a diverse team and leverage and learn from the variety of backgrounds and experiences
Problem solving skills
Experience with Microsoft Office tools
Knowledge of manufacturing, analytical & regulatory regulations (desirable)
Competencies:
Stretch to go beyond the level we have operated at up until now
Take actions instead of waiting to be told what to do
Act in the interest of our patients and customers
*Put the interests of the organization ahead of my own or those of our team
Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.
