Validation Specialist - Remote

Overview

The Validation Specialist plays a crucial role in ensuring that systems, equipment, processes, and software in the pharmaceutical industry meet regulatory and internal quality standards. This position involves planning, executing, and documenting validation activities to support clinical research and improve patient outcomes.

In Short

• Oversee GxP-impacting systems at WEP Clinical.
• Ensure effective risk management and validation planning.
• Author and review validation-related documentation.
• Develop and execute validation protocols (IQ, OQ, PQ).
• Collaborate cross-functionally for validation readiness.
• Conduct impact assessments and change controls.
• Assist during regulatory inspections and audits.
• Identify opportunities for process improvement.
• Maintain validation lifecycle documentation.
• Work with warehouses for temperature mapping.

Requirements

• Bachelor's Degree in pharmaceutical, life sciences, or engineering.
• 2-5 years of validation experience in pharmaceutical or biotech industry.
• Expert knowledge in GAMP5 and regulatory requirements.
• Experience in equipment qualification and process validation.
• Strong documentation and communication skills.
• Proficiency in Microsoft Office, especially Excel.
• Strong organisational skills and attention to detail.
• Ability to work with cross-functional teams.
• Proactive and solutions-driven mindset.
• Ability to quickly learn different systems and assess risks.

Benefits

• Opportunity to contribute to meaningful clinical research.
• Dynamic and collaborative work environment.
• Continuous improvement and innovation encouraged.
• Supportive team dedicated to advancing healthcare solutions.