QA Lead, API External Manufacturing & Quality Assurance

Regulatory Jobs; Indianapolis (IN); Presencial; USD 66 000 - 172 000; Tempo integral

Resumo da oferta

Lilly is seeking an API EM Quality Assurance Consultant to provide critical QA support at contract manufacturing sites from Indianapolis, IN. The role ensures batches meet specs and comply with cGMPs, while coordinating with Lilly QA management.

Key duties include overseeing CM quality activities, supporting regulatory inspections, and maintaining quality agreements. Requires a science degree and 2+ years GMP API/pharma experience, with up to 20% travel.

Qualificações

• Bachelor's degree in a science-related field.
• At least 2 years GMP manufacturing experience in API or Pharma.
• Authorized to work in the United States on a full-time basis.
• Experience with quality systems and regulatory requirements preferred.

Responsabilidades

• Serve as liaison between CM and Lilly for quality matters.
• Provide quality oversight of CMs and be the initial contact for quality issues.
• Escalate quality issues to Lilly QA management.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and MRDs.

Conhecimentos

Quality oversight

GMP experience

Regulatory knowledge

Documentation skills

Communication

Formação académica

Bachelor's in life sciences

Descrição da oferta de emprego

Lilly is seeking an API EM Quality Assurance Consultant to provide critical QA support at contract manufacturing sites from Indianapolis, IN. The role ensures batches meet specs and comply with cGMPs, while coordinating with Lilly QA management.

Key duties include overseeing CM quality activities, supporting regulatory inspections, and maintaining quality agreements. Requires a science degree and 2+ years GMP API/pharma experience, with up to 20% travel.