Validation Consultant (CSV | GxP | Compliance)

Greetings from P360..!

About us:

P360 is an advanced pharma software company specializing in business technology development and implementation for pharmaceutical and life sciences companies worldwide. We specialize in technology that boosts operational efficiency across the entire organization while giving a unique view of how your internal process is functioning and how to improve them.

Role : Validation Consultant (CSV | GxP | Compliance)

Job Summary:

We are seeking an experienced Validation Consultant with strong expertise in Computer System Validation (CSV), GxP compliance, and regulatory requirements. The role involves leading and executing validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), and supporting validation lifecycle documentation to ensure systems meet regulatory standards.

Key Responsibilities:

• Lead and execute Computer System Validation (CSV) activities in compliance with GxP guidelines.
• Develop, review, and execute validation documentation including:
• Validation Plans (VP)
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Risk Assessments
• Traceability Matrix (RTM)
• Perform and document Installation Qualification (IQ) and Operational Qualification (OQ) protocols and reports.
• Support or lead Performance Qualification (PQ) activities where applicable.
• Ensure compliance with global regulatory standards such as:
• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5 guidelines
• ER/ES
• Collaborate with cross-functional teams including QA, IT, and business stakeholders.
• Conduct gap assessments and remediation activities for existing systems.
• Support audits and inspections by preparing validation documentation and responding to queries.
• Ensure data integrity, security, and system compliance throughout the validation lifecycle.
• Provide guidance on validation strategies and best practices.

Required Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
• 4+ years of experience in CSV and validation within GxP environments (Pharma, Biotech)
• Strong hands-on experience with IQ, OQ documentation and execution.
• In-depth knowledge of regulatory requirements

Excellent documentation, communication, and stakeholder management skills.

Perks & Benefits

• Permanent work-from-home
• Flexi Week culture (5 days / 9-day fortnight)
• Fixed internet allowance
• Other benefits

Note: We will contact candidates who fit the current requirements. If you are not contacted, your information and resume will be kept in our database, so we can contact you when and if we have similar vacancies in the future.