Validation Specialist

Lesaffre Iberica SA; Monza; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

Lesaffre Iberica SA recherche un ingénieur en qualification pour assurer la conformité des machines et des systèmes informatiques selon les normes GMP. Vous serez responsable de la qualification des équipements, de la rédaction de protocoles et de la collaboration sur les procédures s’appliquant à ces systèmes. Ce rôle nécessite un Master en disciplines techniques ou scientifiques et de solides compétences en matière de conformité.

Competenze

• Diplôme requis : Master en technique ou science.
• Connaissances requises concernant cGMP.
• Bonne maîtrise de l'anglais.

Mansioni

• Réaliser des activités de qualification IQ / OQ / PQ et rapport final.
• Rédiger et examiner des protocoles de qualification pour les équipements.
• Collaborer à l'élaboration de procédures associées.

Conoscenze

Connaissance des bonnes pratiques de fabrication (cGMP)

Anglais écrit et parlé

Formazione

Master en matières techniques / scientifiques

Descrizione del lavoro

Execution of all activities related to qualification and periodic requalification of production machines, utilities (e.g. : HVAC, PRW, Compressed Air, Nitrogen, etc.) of the areas with controlled contamination, laboratory equipment and the validation of related computer systems (CSV) in compliance with Good Manufacturing Standards, national and international regulations and company policies.

MAIN RESPONSIBILITIES

• Perform directly, or with the support of external personnel, the qualification activities (IQ / OQ / PQ and Final Qualification Reports) of plants, machines, utilities, controlled contamination environments in compliance with planning;
• Drafting and reviewing qualification protocols for the above GMP equipment;
• Collaborate in the drafting of URS and S.A.T. / F.A.T.;
• Collaborate with reference figures to evaluate and complete the activities required by change control in the field of qualifications, in compliance with the procedures and timescales;
• Collaborate with the reference figures in the drafting and updating of the SOPs related to the management / validation of equipment, utilities and controlled contamination areas.

Qualifications

• Master’s degree in technical / scientific subjects;
• Good knowledge of cGMP;
• Good knowledge of written and spoken English.

Company Description

For over 30 years, Lesaffre has been involved in Human Health & Nutrition as part of its ambition to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech and officially combined it with Lesaffre Human Care to form a new Business Unit named Gnosis by Lesaffre. At Gnosis by Lesaffre, we are committed to cultivating and delivering nutritional actives, probiotics, and nutritional and functional yeasts that benefit human health and wellbeing, thanks to the power of microorganisms and biotransformation processes like fermentation. Put differently, we explore life to improve living. Our vision : At Gnosis by Lesaffre, we strive for a world that moves better, digests better, ages better, feels better, and ultimately lives better thanks to microorganisms and biotransformation.

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