Overview
Quality Project Consultant Jobs in Connecticut, United States at Mantell Associates
Title: Quality Project Consultant
Company: Mantell Associates
Location: Connecticut, United States
Mantell Associates is partnered with a Private Equity company focused on the healthcare space, seeking a Quality Project Consultant to join their team.
Quality Project Consultant – Responsibilities:
Conduct and document investigations related to deviations, complaints, and other quality issues
Manage, issue, revise, and archive quality-related documents, including plans, reports, procedures, and batch records in line with GMP standards
Support Change Control management, overseeing revisions to analytical methods, equipment installations, and qualifications
Manage supplier documentation, including records for contract manufacturers and other GMP-related outsourced services
Maintain up-to-date knowledge of procedures, specifications, and regulations relevant to the role
Coordinate inspection readiness activities for the Quality department, including self-inspections, site audits, and inspections
Oversee calibration and maintenance plans and activities
Lead compliance efforts, focusing on risk management and design control
Provide Quality Assurance leadership across GMP quality systems and activities, ensuring high standards throughout all phases of development
Serve as a core project team member, guiding quality and compliance in new project initiatives
Define Qualification and Validation requirements, leveraging a risk-based approach with relevant tools and methodologies
Ensure regulatory guidance during project implementation, representing Quality in discussions with INFARMED, FDA, and other regulatory bodies
Quality Project Consultant – Requirements:
Degree in Biotechnology, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biochemistry, or a related field
Strong proficiency in English (written and spoken)
Minimum of 4 years of Quality Assurance experience in the pharmaceutical or medical industries
Demonstrated experience in developing, improving, and maintaining Infarmed and ISO-compliant QMS
In-depth knowledge of product development, manufacturing, supplier management, quality control, and handling customer complaints
Expert understanding of advanced CQA systems and CQA metrics
Experience with EUGMP
In-depth knowledge of international and national guidelines for medicine production (GMP)
Education or experience in Quality Sciences
Experience in biologics development/production
Familiarity with FDA standards and requirements
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
