Senior QA Qualification and Validation Specialist

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>Join our collaborative team as a Senior QA Qualification and Validation Specialist at Thermo Fisher Scientific, where you&#39;ll contribute to global healthcare and scientific advancement. In this role, you&#39;ll be responsible for ensuring compliance, quality, and operational excellence across our facilities through comprehensive qualification and validation activities. Working with advanced technologies and diverse teams, you&#39;ll help maintain high standards in pharmaceutical manufacturing, systems qualification, cleaning validation, computer systems validation, and quality control.</p><p></p><p><b>Responsibilities:</b></p><ul><li>Support and oversee GMP-compliant commissioning and qualification activities for facilities, utilities, and equipment, working closely with Engineering Services and validation teams to ensure systems are ready for commercial production.</li><li>Participate in the assessment and management of issues and deviations arising during commissioning and qualification activities, in collaboration with Engineering and validation teams.</li><li>Contribute to maintaining and continuously improving quality standards within assigned quality systems and related production areas.</li><li>Support knowledge sharing within the department and contribute to continuous improvement initiatives.</li><li>Act as QA representative within assigned commissioning and qualification teams.</li><li>Review and approve relevant commissioning and qualification documentation in accordance with internal quality standards.</li><li>Review and assess project-related deviations and open items identified during commissioning and qualification activities.</li><li>Support the creation and update of governing documents (e.g., SOPs and work instructions) related to commissioning and qualification activities, under supervision.</li></ul><p><br /><b>Requirements:</b></p><ul><li>Degree (Bachelor or Masters) in Engineering or Life Science (Biology, Chemistry, etc.) Dipl. Ing. Or M.Sc. Or B.Sc. or equivalent.</li><li>Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)</li><li>Experience with commissioning, qualification (DQ/IQ/OQ/PQ), and requalification protocols and reports</li><li>Proficiency in risk assessment and gap analysis</li><li>Strong data analysis and problem-solving capabilities</li><li>Clear verbal and written communication skills</li><li>Knowledge of calibration and metrology principles</li><li>Experience with automation systems and computer system validation</li><li>Effective interpersonal skills for team collaboration</li><li>Experience with quality management systems and documentation</li><li>Experience in quality review of quality records, such as deviations, CAPAs and Change Controls.</li></ul><p></p><p>We offer competitive remuneration. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!</p><p></p><p></p><p></p><p></p>