QA Validation Contractor

Walker Cole International is seeking a knowledgeable and hands-on QA Validation Specialist to support and oversee quality assurance and validation activities to ensure compliance with applicable regulatory requirements and internal quality standards.

As the QA Validation Specialist, your responsibilities will include:

• Review and approve validation protocols (IQ/OQ/PQ), validation master plans, and final reports for equipment, systems, processes, cleaning, and computer systems.
• Ensure all validation activities meet current Good Manufacturing Practices (cGMP), FDA, EU, and other applicable regulatory standards.
• Participate in risk assessments and change control processes to determine validation impact and requirements.
• Maintain traceability of validation documentation and ensure timely review and archival according to company procedures.
• Contribute to the continuous improvement of QA and validation processes, procedures, and templates.

To be successful as the QA Validation Specialist, you will have:

• Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Chemistry, Biology, Engineering).
• 10+ years of experience across QA and validation role in a regulated industry (e.g., pharmaceuticals, biotechnology).
• Strong knowledge of validation principles and regulatory guidelines (21 CFR Part 11, EU Annex 11, ICH, etc.).
• Excellent documentation practices and attention to detail.
• Experience in computer system validation (CSV) or data integrity (DI) compliance (Preferred).

Contract Details:

• Length of assignment: 12 month contract 
• 5 days onsite - Full-time
• Location: Europe
• Pay: Hourly
• Start date: ASAP

Validation l Qualification l CQV l C&Q l QA l Quality Assurance l Quality l GMP | Good Manufacturing Practice | Interim l Contract l Contractor l Pharmaceutical | Pharma l CDMO