Senior Assistant, Quality Assurance – Document Control

Eli Lilly and Company; Alzey; Vor Ort; EUR 40.000 - 80.000; Vollzeit

Zusammenfassung

A forward-thinking company is seeking experienced quality assurance associates to join their team in Alzey, Germany. This role offers a unique opportunity to contribute to new manufacturing investments and pioneering technologies in the pharmaceutical industry. You will be responsible for managing document control processes, ensuring compliance with global standards, and supporting audits. If you have a strong background in document management and a passion for improving healthcare, this position is perfect for you. Join a team that values dedication and innovation in making life better for people worldwide.

Qualifikationen

• 3+ years of experience in the pharmaceutical industry with document management.
• Experience in quality systems and electronic tracking of documentation.

Aufgaben

• Maintain GMP Library document inventory control and compliance.
• Support audits by providing accessible records for review.

Kenntnisse

Document Management

Project Management

Problem Solving

Communication Skills

Teamwork

Ausbildung

High School Diploma or Equivalent

Tools

Microsoft Office

Veeva Vault QualityDocs

Jobbeschreibung

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.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

Key Objectives/Deliverables:

1. Maintain GMP Library document inventory control through the Lilly Record Manager (LRM) system, as required.
2. Create and run reports in LRM to check inventory in the system on a semi-annual basis as a Record Administrator (RA).
3. Maintain Document Controller role for all documents and records maintained in Veeva Quality Docs Electronic Document Management System (EDMS).
4. Ensure compliance to global and local Documentation and Records Management requirements.
5. Create, update, and route documents for review and approval in the EDMS.
6. Support other functions with the creation, update, routing, review and approval of electronic documents by appropriate Lilly personnel.
7. Manage and monitor assigned Veeva Vault QualityDocs workflows.
8. Meet with Lilly internal personnel to review documents and assign Veeva Quality Docs meta data when adding documents into the Veeva Quality Docs EDMS.
9. Manage Retention of GMP Related Records in accordance with Document Type and Record Class Codes (RCC). This includes shipment of GMP records to External storage location for long term retention as necessary.
10. Manage controlled print of GMP forms and facilitate reconciliation process for executable records.
11. Support external and internal audits through providing readily accessible records as requested for review by Regulatory Agency and Notified bodies, and/or Lilly internal auditing and compliance groups.
12. Support Site Self Inspections associated with Document Control and the Veeva Vault Q Docs Electronic Data Management System (EDMS).
13. Monitor and ensure that document periodic reviews are performed within Veeva Vault QualityDocs according to Lilly standards.
14. Follow up with document owners to ensure review and updating on a timely basis.
15. Work closely with Quality, Learning and Development, and other Lilly functions to ensure their document needs are captured as required.

Basic Requirements:

• High school diploma or equivalent
• Minimum 3 years in the pharmaceutical industry with previous document management experience.
• On-site presence required.

Additional Skills/Preferences:

• Experience with Microsoft Office (e.g., Outlook, Word, Excel).
• Previous experience in records management, data entry, or similar experience.
• Demonstrated ability to work successfully in a team environment.
• Demonstrated Project Management skills.
• Strong written and verbal communication skills.
• Strong ability to solve problems and make decisions.
• Experience with documentation in a GMP environment and electronic tracking of documentation.
• Experience in quality systems such as Veeva Vault QualityDocs.

Additional Information:

• Primary location is Alzey, Germany.
• Ability to work overtime as required.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.