Hands-On Qualification & Validation Specialist

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

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.