Quality Manager

About the role

Quality Chemical Laboratories (QCL), a pharmaceutical testing, manufacturing, and development lab in Wilmington, is seeking a highly motivated Quality Manager for our Sterile fill-finish parenteral manufacturing facility.

Requirements

• High-level quality experience in sterile manufacturing
• Knowledge of 21 CFR parts 210 and 211
• Knowledge of the FDA Guidance for Sterile Drug Products Produced by Aseptic Processing - cGMP
• Knowledge of EU GMP Annex 1: Manufacture of Sterile Medicinal Products

Responsibilities

• Manage the quality team
• Establish the quality policy for media fills, parenteral manufacturing, and quality procedures that support parenteral manufacturing
• Review qualification and validation documents for all processes and equipment, including protocols and summary reports
• Conduct risk assessments and investigations
• Develop SOPs to support the quality program
• Establish the sterility assurance plan and contamination control strategy