Validation Specialist

Buscojobs; Sardegna; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

Une entreprise leader dans le domaine de la santé et de la nutrition recrute pour un poste de qualification des équipements de production. Le candidat idéal aura un Master en discipline technique, une bonne connaissance des normes GMP et la capacité de travailler en anglais. Les responsabilités incluent la qualification d'équipements, la rédaction de rapports et la collaboration avec les équipes de changement.

Competenze

• Diplôme de Master dans des disciplines techniques ou scientifiques.
• Bonne connaissance des cGMP.
• Proficient en anglais écrit et parlé.

Mansioni

• Réaliser des activités de qualification d'équipements et de systèmes selon les normes GMP.
• Rédiger et revoir les protocoles de qualification.
• Collaborer à la rédaction des URS et des SAT.

Conoscenze

cGMP

Anglais

Formazione

Master’s degree in technical or scientific disciplines

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.), 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, qualification activities (IQ / OQ / PQ and Final Qualification Reports) of plants, machines, utilities, and controlled contamination environments in accordance with planning;
• Draft and review qualification protocols for GMP equipment;
• Collaborate in drafting URS and S.A.T. / F.A.T.;
• Work with relevant personnel to evaluate and complete activities required by change control related to qualifications, ensuring compliance with procedures and deadlines;
• Assist in drafting and updating SOPs related to the management and validation of equipment, utilities, and contamination control areas.

QUALIFICATIONS

• Master’s degree in technical or scientific disciplines;
• Good knowledge of cGMP;
• Proficiency in written and spoken English.

Company Description

For over 30 years, Lesaffre has been dedicated to Human Health & Nutrition as part of its mission to Better Nourish and Protect the Planet. In November 2018, Lesaffre acquired Gnosis Advanced Biotech, merging it with Lesaffre Human Care to form Gnosis by Lesaffre. We are committed to developing and delivering nutritional actives, probiotics, and functional yeasts that promote human health and wellbeing, leveraging microorganisms and biotransformation processes like fermentation. Our vision: At Gnosis by Lesaffre, we aim for a world that moves better, digests better, ages better, feels better, and lives better through microorganisms and biotransformation.

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