Site Self-Inspection QA Lead – 1st Shift

1100 Mylan Pharmaceuticals Inc.; St. Albans, Northern (VT, KY); Hybrid; USD 95,000 - 193,000; Full time

Job summary

Mylan Technologies, Inc. in St. Albans, Vermont, seeks a Site Self Inspection Lead in Quality Assurance on first shift.

You will create and track the site self-inspection plan, coordinate with Site Leadership and Global Operations Auditing, and lead self-inspections ensuring proper recording and communication. Responsibilities include evaluating CAPA items, verifying effectiveness, preparing annual trend reports, facilitating bi-monthly reviews, managing the Site Audit Module, supporting the

Qualifications

• Extensive knowledge of pharmaceutical quality systems and global GMPs.
• Experience applying GMPs to site systems and processes.
• Strong understanding of regulatory expectations (FDA, EMA, ICH, ISO 9001).

Responsibilities

• Create and manage the site self-inspection plan and agenda.
• Lead site self-inspections and ensure appropriate recording and communication.
• Evaluate and track CAPA items and verify effectiveness.
• Prepare annual trend reports and coordinate with Global Operations Auditing.

Skills

GxP Compliance

Quality Assurance

cGMP knowledge

Audit readiness

Education

Bachelor's degree in Science/Engineering

Job description

Mylan Technologies, Inc. in St. Albans, Vermont, seeks a Site Self Inspection Lead in Quality Assurance on first shift.

You will create and track the site self-inspection plan, coordinate with Site Leadership and Global Operations Auditing, and lead self-inspections ensuring proper recording and communication. Responsibilities include evaluating CAPA items, verifying effectiveness, preparing annual trend reports, facilitating bi-monthly reviews, managing the Site Audit Module, supporting the