QA - QP Support Coordinator

仕事内容

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 35,000 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 ELECTS QA packaging and QP team, this position is responsible for:

• Coordinating timely execution of support activities related to QP involvement in CT Applications (key contact for the creation of the QP declaration, review documents to be shared with authorities, manage the GMP certificate, collect appropriate metrics related to this activity, answer to question from competent authorities)
• Support the GDP responsible person in her/His duty.
• Acting as a back-up ELECTS QA Packaging representative. 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.
• Supporting activities performed by ELECTS QA and Lilly PR&D QA groups
  

Key Responsibilities

QP Declaration / CT Applications / RP support

• Actively participate to Kick Off meetings for EU CTA.
• Issue or review QP declarations and GMP certificates in accordance with EU and GMP / GDP Regulations
• Provide answers to competent authorities questions related to GMP documentation, in collaboration with the ELECTS QP
• Provide GMP support documentation for submission of new study as required by EU CTA procedure and ensure proper classification, storage, archiving and destruction.
• Collect relevant metrics periodically.
• Ensure continuous updating and maintaining of the Authorized Facilities List with supportive documentation from GQAAC Audit reports
• provide support to the Responsible Person in ensuring compliance of the supply chain
  

Documentation

• Maintenance in Lilly electronic database of Quality Agreements/IIR Technical Agreements for which ELECTS performs GMP activities
• Maintain Site Master File
• Support for EP QP activities
• Issue Bio API certification documentation
• Act as coordinator to manage the activities for 1 Series within Lilly PR&D Quality System
• Management of QP declaration files, Manufacturing Authorization, GMP Certificates
• Day to day Maintenance of Declaration 581
• Actively participate in populating Lilly and non-Lilly databases used in packaging/labelling department, this includes but not limited to: SAP, TrackWise, Metrics Database.
• Actively participate in the PR&D Quality System by identifying, reviewing of procedures, tools or any other documents that require QA approval
  

Back-up For Packaging/Labelling QA Activities

• 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.
• 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

• Handles notifications from MOH/agencies related to falsified product
• Ensure regulatory and GMP/GDP requirements are met for activities performed.
• Ensure compliance of the supply chain requirement of EU GMP Annex 16
• Issue detailed supply chain mapping for high-risk products and medium-risk dry products
• Ensure documents are handled and stored in compliance with Lilly Quality System Requirements.
• Ensure monitoring of changes in regulations affecting ELECTS activities
  

External relations/others

• Interact with the PD team as well as Global Quality Development Units and Business Units.
• Interact with the Regulatory teams and Regulatory Authorities
• Collaborate to projects and actions related to packaging/labelling activities
• Interact with the CPs involved in Packaging/Labelling activities and other contracting Manufacturers
  

Health, Safety and Environment

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

Confidentiality

• Ensure that confidential information remains confidential.

Requirements:

• Preferably a scientific Master Degree, Qualified Person
• 2 years in pharmaceutical environment
• Ideally with Responsible Person experience
• Must speak and write fluent English
  

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.