Qualification & Validation Associate — Biopharma Impact

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

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.