CSV Consultant

ARM International; Barcelona; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

ARM International is seeking a Computer System Validation (CSV) Consultant to join its growing life sciences consultancy team. The role focuses on leading CSV activities across pharma, biotech, and medical device projects in a collaborative, international environment.

You will author and review validation plans, URS, risk assessments, IQ/OQ/PQ protocols, and summary reports, while ensuring compliance with GMP, GxP, Annex 11, and 21 CFR Part 11 across multiple client engagements.

Qualifikationen

• Minimum 5 years' experience in Computer System Validation within pharmaceutical, biotechnology or medical device environments.
• Strong understanding of GMP, GxP, Annex 11 and 21 CFR Part 11 requirements.
• Experience validating systems such as Veeva Vault, TrackWise, SAP, LabWare, LIMS, eQMS platforms.
• Strong stakeholder management and communication skills.

Aufgaben

• Lead and support CSV activities across a range of life sciences clients.
• Author and review validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols and summary reports.
• Support validation and qualification activities for GxP-regulated systems and applications.
• Work with cross-functional stakeholders to ensure compliance with GMP, GxP, Annex 11 and 21 CFR Part 11 requirements.
• Participate in system implementations, upgrades and remediation activities.
• Provide expert validation guidance to clients throughout project lifecycles.
• Support audits, inspections and quality initiatives where required.

Kenntnisse

Stakeholder management

Communication skills

Tools

Veeva Vault

TrackWise

SAP

LabWare

LIMS

eQMS

Jobbeschreibung

A leading international life sciences consulting organisation is seeking a Computer System Validation (CSV) Consultant to join its growing team. With a strong presence across the pharmaceutical, biotechnology and medical device sectors, the business partners with clients to deliver quality, compliance, validation and digital transformation projects across highly regulated environments.

This is an excellent opportunity for a validation professional who enjoys working across multiple client projects and is looking to further develop their consulting career within a collaborative, international environment.

Key Responsibilities:

• Lead and support Computer System Validation (CSV) activities across a range of life sciences clients.
• Author and review validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols and summary reports.
• Support validation and qualification activities for GxP-regulated systems and applications.
• Work with cross-functional stakeholders to ensure compliance with GMP, GxP, Annex 11 and 21 CFR Part 11 requirements.
• Participate in system implementations, upgrades and remediation activities.
• Provide expert validation guidance to clients throughout project lifecycles.
• Support audits, inspections and quality initiatives where required.

Requirements:

• Minimum 5 years' experience in Computer System Validation within pharmaceutical, biotechnology or medical device environments.
• Strong understanding of GMP, GxP, Annex 11 and 21 CFR Part 11 requirements.
• Experience validating systems such as: Veeva Vault, TrackWise, SAP, LabWare, LIMS, eQMS platforms
• Strong stakeholder management and communication skills.