Quality Assurance Packaging Coordinator

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Main Purpose and Objectives of Position:

As a member of the Packaging quality team, this position is responsible for:

• Coordinating day to day QA Packaging activities (acting as front line for minor operational issues, managing prioritization, escalating issues to management, communicate periodic status to supply planning).
  
• Ensuring the Quality oversight of packaging and labelling operations of Clinical Trials (CT) performed by Collaboration Partners (CPs) and Alliance Partners located in the EU and Asia are in compliance with both regulatory and Lilly Corporate GMP/GDP requirements/standards for CTs supplies.
  
• Ensure compliance with EU and Belgian regulatory requirements, GMP/GDP and Lilly standards of activities performed on behalf of ELECTS and Lilly.
  
• Working with the PD and PR&D functions as well as key members of the Global Quality Development Unit, Business Partners, CPs and Regulatory Affairs.
  
• Contributing to the realization of the Quality Objectives in connection with the GMP's activities of PR&D.
  

Key Responsibilities

Packaging/Labelling QA Activities

• Attend daily meeting with management and supply planning to provide updates on batch release and priorities
  
• Communicate priorities to the QA packaging group to ensure on time release activities
  
• Participate into triages and act as the quality representative for packaging issues
  
• Updating the Quality Managers/QPs/RPs of any non-conformity and/or issues that may affect quality and/or integrity of the CT Materials (finished and/or semi-finished).
  
• Maintaining deep knowledge/expertise with the packaging/labelling processes.
  
• Creating a direct link between Lilly and Partners (business, CPs, etc…) for Quality activities.
  
• Act as a Subject Matter Expert in link with the Quality Packaging partners from the US.
  
• Participate in the Quality oversight of the CPs with the Qualification Representative through metrics analysis, trending, PiPs, etc. as applicable.
  
• Reviewing/approving incomings used in packaging/labelling operations.
  
• Reviewing/ approving instructions for packaging/labelling operations and packaging/labelling batch records for studies performed by the different collaboration and alliance partners.
  
• Participating in deviation assessments/investigations/approval related to Packaging/Labelling activities.
  
• Participating in change control assessments/review/approval related to Packaging/Labelling activities.
  
• Reviewing Standards/Procedures/Tools and reference documents from Lilly Quality Systems related to Packaging/Labelling activities.
  
• Reviewing DCPR/QA with CPs.
  
• Conducting self-inspections.
  
• Participating in regulatory inspections and ensure audit readiness.
  

Compliance:

• Ensure regulatory (GMP/GDP) requirements are met for activities performed
  

Documentation

• Ensure documentation produced is handled and stored in compliance with our Quality System Requirement.
  
• Actively participate in populating Lilly and non-Lilly databases used in packaging/labelling department, this includes but not limited to: SAP, TrackWise, Metrics Database.
  

People Management

• Manage QA Packaging team at ELECTS
  
• Responsible for establishing proper job descriptions based on roles and responsibilities of each function within a group.
  
• Responsible for ensuring people receive appropriate training to perform their jobs.
  
• Manage the workload and tasks distribution among the team to ensure all activities and actions are done and completed according to agreed timelines and with quality performance.
  
• Responsible for recruiting, hiring, and effective " on-boarding" and integration of new people to the team.
  
• Provide leadership and direction to people regarding policies, organizational goals, objectives goals, objectives, performance management and company policies.
  
• Responsible for coaching and mentoring people for excellence.
  
• Oversee employee qualification files (Job description, CVs, training records).
  

Training

• Guide and advice on GDP/GMP matters.
  
• Participate in the training of newcomers in the QA Packaging team.
  

External relations/others

• Build a strong relationship with US Packaging/QA Packaging to ensure efficient collaboration and global updates properly communicated
  
• Interact with the Clinical Supply and Delivery team.
  
• Interact with the CPs involved in Packaging/Labelling activities.
  
• Interact with the Regulatory teams.
  
• Collaborate to projects and actions related to packaging/labelling activities.
  
• Serve as a back-up for the rest of the team to support relevant activities.
  

Health, Safety and Environment

• Carry out the activities in accordance with company and site safety and environmental requirements.
  

Quality Culture

• Make quality culture the foundation of your work, to ensure our products are safe and effective to improve patients' lives.
  
• Maintain ownership and emphasis on quality, ensuring quality in all daily activities.
  
• Demonstrate engagement and employ a quality mindset in all endeavours by proactively identifying quality issues and communicate appropriately.
  

Requirements

• Scientific Bachelor or Master degree
  
• 2 years experience within pharmaceutical environment
  
• Experience within QA
  
• Excellent team player and strong communication skills
  
• Must speak and write fluent English, next to French
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.