QUALIFICATION AND VALIDATION – ASSISTANT

Recipharm; Lisboa; Presencial; EUR 28 000 - 38 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary and benefits

Growth opportunities

Collaborative working environment

Resumo da oferta

GenIbet in Lisbon, Portugal is seeking a Qualification and Validation Assistant to support the preparation, review and approval of GMP documentation, and to assist in qualification activities for equipment, systems and utilities.

The role requires a BSc/MSc in engineering or related field, 3 years in the pharmaceutical industry, fluency in English, and a hands-on, team-oriented mindset with strong problem-solving skills.

Qualificações

• 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).
• Fluent in English.
• Passion for hands-on, on-field work.
• Team player.

Responsabilidades

• 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
• Facilitator between different departments: Production, QC and Maintenance

Conhecimentos

Fluent in English

Team player

Problem-solving

Hands-on

Formação académica

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

Descrição da oferta de emprego

POSITION NAME

QUALIFICATION AND VALIDATION – ASSISTANT

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
• Facilitator between different departments: Production, QC and Maintenance

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)
• Fluent in English
• 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.