-
Job Description
Ensure compliance and quality in biologics manufacturing, overseeing processes, and investigating non-compliance issues to maintain regulatory standards.
Responsibilities:
- Ensure products meet standards for marketed and investigational drug products.
- Provide quality and compliance oversight to the Operations function.
- Lead/Assist in investigations arising out of product or manufacturing processes non-compliance.
- Review/Audit completed Batch Records and Manufacturing Logs.
- Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
- Complete Line Clearance activities and Incoming Raw Material checks.
- Provide Stability Program Support and maintain finished product status.
- Administer Quality Logs and lead operations floor daily walk-around of manufacturing areas.
- Drive continuous improvements and simplify site processes and procedures.
Requirements:
- Third level degree in a science, quality, or engineering discipline.
- Previous experience in a quality role is ideal.
- A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment.
- Experience in biologics manufacturing and aseptic processing is highly desirable.
- A strong knowledge of regulatory requirements is required.