QUALIFICATION AND VALIDATION – ASSISTANT

Recipharm AB; Lisboa; Presencial; EUR 28 000 - 36 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Growth opportunities

Collaborative environment

Global projects

Resumo da oferta

GenIbet, a cGMP biopharmaceutical CDMO, is seeking an Assistant for Qualification and Validation in Lisbon to support the preparation, review and approval of GMP documentation, and the qualification of equipment and computerized systems.

Requirements include a BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering, 3 years in pharma, knowledge of FDA/EMA/GAMP 5/ISPE, and hands-on experience with HVAC and WFI qualifications.

Qualificações

• Degree in Chemical, Biological, Mechanical or Industrial engineering or related field.
• 3 years of experience in the Pharmaceutical Industry.
• Knowledge of FDA, EMA, GAMP 5, ISPE.
• Experience with qualification of equipment, systems and utilities (HVAC, WFI).
• Hands-on, on-field work.
• Team player and problem-solver.

Responsabilidades

• Prepare, review, and approve GMP documentation (URS, risk assessment, Master plans, qualification/validation protocols).
• Support qualification of equipment and computerized systems.
• Manage Deviations, CAPAs and Change Control activities.
• Create and revise procedures for equipment, facilities and computerized systems.
• Update asset management software.
• Plan and deliver tasks independently according to timelines.

Conhecimentos

GMP knowledge

Team player

Problem solving

Critical thinking

Formação académica

BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering

Ferramentas

HVAC

WFI

Descrição da oferta de emprego

QUALIFICATION AND VALIDATION – ASSISTANT Lisbon

COMPANY DESCRIPTION:

GenIbet is a cGMP biopharmaceutical CDMO - Contract Development Manufacturing Organization - offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies.

GenIbet's core activity is the manufacture and supply of materials for use in early-stage drug development, pre-clinical studies and cGMP manufacturing for clinical trials and commercial.

RESPONSABILITIES:

• Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation protocols)
• Support the qualification of equipment’s and computerized systems
• Operational handling of management of Deviations, CAPAs and Change Control activities
• Creation and revision of procedures related to equipment, facilities and computerized systems
• Update of the asset management software
• Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines

REQUIREMENTS:

• BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering or other relevant area
• 3 years of experience in the Pharmaceutical Industry
• Knowledge of industry regulations and standards (FDA, EMA, GAMP 5, ISPE)
• Experience with the qualification of equipment, systems and utilities (HVAC, WFI)
• Passion for hands-on, on-field work
• Team player
• Problem-solving and critical thinking skills

OFFERED:

• Competitive salary and attractive benefits
• Opportunities for professional growth and development
• Innovative and collaborative working environment
• Participation in challenging projects with a global impact.

Be part of a team that is changing the future in the field of Biologics with innovation, passion and excellence. We look forward to receiving your application!