Quality Consultant Lisboa

Quality Consultant
Lisboa
Lisboa, Lisboa, Portugal

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Divisional Manager - Contract at Mantell Associates

Mantell Associates is partnered with an innovative biopharmaceutical company seeking a Quality Consultant to join their team.

Quality Consultant - Responsibilities:

• Conduct and document investigations related to deviations, complaints, and other quality issues
• Manage, issue, revise, and archive
  - 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
  -
  - date knowledge of procedures, specifications, and regulations relevant to the role
• Coordinate inspection readiness activities for the Quality department, including
  - 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
  - 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 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
• Familiarity with FDA standards and requirements

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Legal, Quality Assurance, and Other

Industries

Biotechnology Research, Pharmaceutical Manufacturing, and Chemical Manufacturing

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.