CSV Consultant

Hobson Prior; Madrid; Híbrido; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

An innovative firm is seeking a Principal Consultant - Engineering to join their dynamic team. This exciting contract role offers flexible remote work options while focusing on technical operations quality within the biotechnology industry. Ideal candidates will possess practical experience in IT quality and compliance, alongside strong communication and stakeholder management skills. You will engage with manufacturing systems, ensuring compliance with regulations and guidelines while utilizing various tools for system qualifications. If you're passionate about making a difference in the life sciences sector, this opportunity is perfect for you.

Formación

• Practical experience in IT quality and compliance is essential.
• Familiarity with computer system validation and software testing required.

Responsabilidades

• Manage operational tasks at manufacturing sites.
• Write and manage qualification and validation documents.

Conocimientos

IT quality and compliance

Communication skills

Stakeholder management

Data migration

Information security

Understanding of pharmaceutical and life sciences

Herramientas

Kneat

HP ALM

SNOW

MES

QMS

LIMS

Descripción del empleo

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Principal Consultant - Engineering at Hobson Prior

Hobson Prior is seeking a CSV Consultant for a contract role with flexible remote work options and project sites across Italy, Spain, and the Czech Republic. This position focuses on technical operations quality and IT within the biotechnology industry.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Work on manufacturing sites to manage operational tasks.
• Understand data migration, information security, and compliance principles.
• Follow regulations and guidelines like 21CFR Part 11 and EU annex 11.
• Write and manage qualification and validation documents.
• Address defects, conduct investigations, and manage corrective actions.
• Use tools like Kneat, HP ALM, and SNOW for system qualifications.
• Work with standalone and integrated manufacturing systems.

Key Skills and Requirements:

• Practical experience in IT quality and compliance.
• Familiarity with computer system validation and software testing.
• Knowledge of manufacturing, quality, and engineering systems.
• Strong communication and stakeholder management skills.
• Understanding of pharmaceutical and life sciences domains.
• Experience with systems like MES, QMS, LIMS, and business analytics is beneficial.

For more information, please contact Jack Keens.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Science
• Professional Services