Senior QA Qualification and Validation Specialist

About the job

Work Schedule

Environmental Conditions

Job Description

Join our collaborative team as a Senior QA Qualification and Validation Specialist at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. In this role, you'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'll help maintain high standards in pharmaceutical manufacturing, systems qualification, cleaning validation, computer systems validation, and quality control.

Responsibilities:

• 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.
• Participate in the assessment and management of issues and deviations arising during commissioning and qualification activities, in collaboration with Engineering and validation teams.
• Contribute to maintaining and continuously improving quality standards within assigned quality systems and related production areas.
• Support knowledge sharing within the department and contribute to continuous improvement initiatives.
• Act as QA representative within assigned commissioning and qualification teams.
• Review and approve relevant commissioning and qualification documentation in accordance with internal quality standards.
• Review and assess project-related deviations and open items identified during commissioning and qualification activities.
• Support the creation and update of governing documents (e.g., SOPs and work instructions) related to commissioning and qualification activities, under supervision.

Requirements:

• Degree (Bachelor or Masters) in Engineering or Life Science (Biology, Chemistry, etc.) Dipl. Ing. Or M.Sc. Or B.Sc. or equivalent.
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
• Experience with commissioning, qualification (DQ/IQ/OQ/PQ), and requalification protocols and reports
• Proficiency in risk assessment and gap analysis
• Strong data analysis and problem-solving capabilities
• Clear verbal and written communication skills
• Knowledge of calibration and metrology principles
• Experience with automation systems and computer system validation
• Effective interpersonal skills for team collaboration
• Experience with quality management systems and documentation
• Experience in quality review of quality records, such as deviations, CAPAs and Change Controls.

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!