Mantell Associates
Mantell Associates is partnered with an innovative biopharmaceutical company seeking a Quality Management System (QMS) Consultant to join their team.
QMS 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
QMS 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.