Senior QA Qualification and Validation Specialist(m/w/x)

Description

You will ensure operational excellence by overseeing GMP-compliant qualification activities, collaborating with diverse teams to maintain high standards across the company's pharmaceutical facilities.

Requirements

• •Degree in Engineering, Life Science, or equivalent
• •Knowledge of cGMP, FDA, and industry standards
• •Experience with commissioning and qualification protocols
• •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 and computer validation
• •Effective interpersonal skills and team collaboration
• •Experience with quality management systems
• •Experience in quality review of records

Tasks

• •Oversee GMP-compliant commissioning and qualification for facilities and equipment
• •Collaborate with Engineering Services to prepare systems for commercial production
• •Assess and manage issues arising during commissioning and qualification
• •Improve quality standards within assigned systems and production areas
• •Share knowledge and contribute to continuous improvement initiatives
• •Act as the QA representative within qualification teams
• •Review and approve commissioning and qualification documentation
• •Assess project-related deviations and open items
• •Update SOPs and work instructions for qualification activities

Tools & Technologies

Benefits