Job Description

Mission:

The primary goal of this mission is to manage projects effectively, ensuring alignment with our standards and operational excellence.

We have identified several gaps between Annex 1 and our standards through a Quality Risk Management (QRM) process. The projects are diverse and include:

• PUPSIT
• Single Use Integrity System
• Revamping of a filling line (HVAC, automation, EMS, etc.)
• Gap Assessment on filling lines (machine modification, reliability, etc.)
• Revamping PAL/MAL
  
  
  

Key Responsibilities:

• Project Management:
• Clearly define the project scope based on gap assessments.
• Identify and discuss various technical options with production, engineering, QA, etc.
• Present options and facilitate decision-making in Steering Committee meetings.
• Post-Decision Execution:
• Engage suppliers for quotations (minimum of 3 offers).
• Develop the Project Charter and define the project scope.
• Establish the budget and prepare the CAPEX request.
• Submit the CAPEX request for approval.
• Project Execution:
• Manage the execution of the project according to the defined scope and workload.
• Ensure follow-up, coordination, and communication with production, QA, and other stakeholders.
• Act as a facilitator to ensure smooth project execution.
• Optionally, oversee subcontracting of execution and follow-up to a defined study office or other resources as outlined in the budget request.
  
  
  

Profile Requirements:

• Experience: Minimum 5-7 years of relevant experience in the pharmaceutical industry.
• Technical Knowledge: Strong understanding of production and technical processes.
• Project Management Skills: Familiarity with the V-model and project management stages.
• Certifications: ASTM 2500 knowledge is a plus.
• Personal Attributes:
• Versatile "Swiss Army knife" profile: adaptable, hands-on, excellent communication skills, and high flexibility.
  
  
  

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.