Quality Assurance Associate Dpem

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.

Act as Site Complaint Coordinator:

- Manage all aspects of Complaints&ICIs system responding to, investigation of and communication of product Complaints&Intracompany Issues (ICIs).
- Build and maintain good communications with External Manufacturers (Ems) and Lilly’s teams related product complaints and ICIs reporting back Drug Product External Manufacturing (DPEM) Management in case of critical issues. Also, respond to requests for data and information.
- Build and maintain good communications with local affiliates. Also respond to requests for data and information.
- Perform internal notification to management of quality issues when needed.
- Follow-up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings related to DPEM complaints&ICIs management system.
- Provide monthly metrics and quarterly reports for inclusion in management reports.
- Support product launch complaint process.
- Continuously identify areas for quality improvements in the Complaints&ICIs management process. Input to Global Complaint Team as needed.
- Attend relevant Complaints Lilly forums, e.g. Manufacturing Site Responsible Complaint Person (RCP) Quarterly Call and Affiliate/Regional Center RCP meeting (Americas/EU/META)

Global Quality Standard (GQS) ownership: 130 Complaints Management

Keep up to date with internal Lilly standards
- Review new and revised GQS and Common Quality Practices (CQPs)
- Determine impact on DPEM and work with manager, Quality System Owner to develop appropriate action plan.
- Help determine training needs for DPEM as appropriate.
- Attend relevant Quality Systems Lilly forums, e.g. quality system forum.
- Initiate and maintain links to global Quality System Owners.
- Provide updates to DPEM at quarterly meetings as appropriate.
- Attendance at relevant industry forums as needed e.g. ISPE, PDA.

Perform Management Review and Governance
- Help gathering data and give feedback on the quarterly review of GQS 130 at Quality Lead Team at least once a year in accordance to GQS 101.
- Highlight issues to Management on a day to day basis if necessary.

Perform role of Power User for the TrackWise complaints module.
- Provide training for the organization and any new starters

Training Coordinator-Back up: administration of training system for DPEM users.

Back up of DPEM’s document management system, including:

- GMP library processes,
- Oversees management of the GMP Library files in compliance with the Global Record Retention Schedule (GRRS) and critical, legal, and regulatory requirements.
- Schedules, coordinates annual records clean-up activities in compliance with the GRRS and reports clean-up day progress and completion upon request.
- Management of destruction requests at the off-site storage location when documents have reached the end of their retention period.
- Maintenance of the electronic library records management system (LRM2) account.
- Participates on GRIM meetings and translates any global update on documentation management to the team.

QualityDocs Business leader-Back up:

- Attend Business User Conference Calls and Meetings.
- Coordinate with the Global QualityDocs Business Team as required on changes, updates and improvements to the system.
- Attend IT conference Calls and Meetings.
- Communicate to DPEM system changes and updates.
- Maintain training material.

Required qualification/characteristics
- Graduate in Chemistry, Pharmacy, or other similar technical background.
- Experience in technical and quality functions within a manufacturing plant, would be appreciated.
- Appreciation of cultural diversity.
- Willingness to travel.

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.

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