Job Title: QA Validation Engineer
Location: Sligo, Ireland
Type: Contract
Duration: 12 months
Rate: €60-€69 per hour
Ref Code: DES-957

REQUIREMENTS

• A qualification and/or degree in an engineering or scientific discipline.
• Over 3 years of working knowledge of cGMP, validation, and regulatory requirements in the biopharmaceutical industry.
• Strong written and oral communication, presentation, and troubleshooting skills.
• Experience in QA Validation of fill lines is an advantage.
• Experience in equipment validation is highly desirable.
  For further information or a chat in confidence please reach out to Nina 087 6272369 or nina@dillones.ie.

• Coordinate and actively participate in the validation and quality assurance of site equipment, utilities, processes, and software in compliance with Company policies, FDA, European cGMP, and GAMP standards.
• Develop and execute the Site Validation Master Plan.
• Create and execute Project Validation Plans and schedules.
• Prepare validation protocols and final reports, ensuring they meet cGMP standards.
• Manage validation investigations and implement corrective actions as needed.
• Review and approve various quality documents and test data.
• Manage validation, exception event, and change control processes.
• Maintain and track validation equipment (if applicable).
• Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
• Coordinate activities to maximize team efficiency.
• Provide cross-training within the team and train new team members as necessary.
• Ensure cGMP compliance of production areas.
• Communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary.