Quality Assurance Manager for Pharmaceutical Packaging in Fairfield

Job Overview

We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for quality aspects related to quality systems in the packaging facility.

The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada).

• Quality Assurance management
• Documentation control (master batch record, specification and method)
• Batch record review and product disposition
• Investigations, complaints, deviations, CAPAs, APRs
• Production and pharmaceutical development support
• APRs, GMP training and SOP review
• Validation / qualification documentation review and approval
• QA operations – inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
• Develop, maintain, and enhance training programs and systems
• Drive key compliance initiatives such as training program enhancements, quality documentation system enhancements, and other identified initiatives
• Must be able to move about the facility
• Experience with FDA audit
• Extensive knowledge of US and EU current Good Manufacturing Practices
• Experience with a CDMO would be preferable

In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for:

We are a pharmaceutical packaging company looking for someone who is proactive and will want to learn and grow.