Validation Specialist

Lesaffre; Pisticci; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Un'azienda innovativa nel settore della salute e nutrizione cerca un professionista per gestire la qualificazione delle attrezzature di produzione. Questa posizione offre l'opportunità di contribuire a progetti significativi in un ambiente di lavoro stimolante. Sarai responsabile della qualificazione di macchinari e sistemi, garantendo la conformità agli standard di buona fabbricazione e alle normative nazionali e internazionali. Se sei appassionato di scienza e desideri fare la differenza nel migliorare la salute umana attraverso la biotecnologia, questa è l'opportunità che fa per te.

Competenze

• Laurea magistrale in materie tecnico/scientifiche richiesta.
• Buona conoscenza di cGMP e competenze in redazione di protocolli.

Mansioni

• Eseguire attività di qualificazione di macchinari e impianti.
• Redigere e rivedere protocolli di qualificazione per attrezzature GMP.

Conoscenze

Conoscenza di cGMP

Competenze in redazione di protocolli

Lingua inglese scritta e parlata

Formazione

Laurea magistrale in materie tecnico/scientifiche

Descrizione del lavoro

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.

Job Description

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

1. 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;
2. Drafting and reviewing qualification protocols for the above GMP equipment;
3. Collaborate in the drafting of URS and S.A.T./ F.A.T.;
4. 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;
5. 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.

Additional Information

Fixed term contract