Medicines Quality Consultant

2 semanas atrás

Sao Paulo, Brasil Eli Lilly Tempo inteiro

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.

The purpose of the Medicines Quality Consultant (MQC) role is to support the development and implementation of quality systems strategy and activities to support MDU goals and objectives for assigned countries. In support of this mission, the purpose of the role of MQC for an Affiliate is to act as a quality consultant and leader in integrating the quality requirements into the business processes. The MQC will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Safety and Efficacy quality system and assuring that this system is aligned with appropriate quality and regulatory requirements. The MQC will provide updates on internal/external GxP trends and changes through Affiliate Integrated Quality Lead Team (IQLT) (where applicable).The MQC will act as a contact person regarding quality and business process compliance concerns between affiliates and global.

**Main Responsibilities**:

- Ensure local implementation of the Safety and Efficacy Quality System (SEQS) Ensure inspection readiness and compliance to global, regional, and/or local regulations
- Ensure the implementation and maintenance of regional and/or affiliate Quality Plan(s)
- Implement and manage Quality Systems
- Drive trending of metrics to improve processes and compliance
- Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections)
- Understand the roles and responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV)

**Minimum Qualification Requirements**:

- Bachelors or Masters Degree in a science or health care related field, Health care professional, i.e., Pharmacist, Nurse
- Three years experience in quality and/or drug product safety/regulatory
- Demonstrated ability to communicate effectively, both written and verbal, and to influence others
- Demonstrated ability to prioritize and handle multiple concurrent tasks

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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