Qualification Specialist (f/m/d)

Purpose of your Job

The position holder is responsible for ensuring the operational support of the Quality Control (QC) unit by managing and maintaining QC laboratory equipment in compliance with Good Manufacturing Practice (GMP) standards. This role involves overseeing system ownership of QC instruments, coordinating equipment maintenance and qualification, and supporting laboratory readiness for audits and inspections. Additionally, the role includes executing routine QC tasks, reviewing documentation, and conducting instrument training to uphold the integrity and efficiency of laboratory operations.

Your Responsibility

• Execution of compilation and review of SOP, QC templates and reports
• Support in the cause of preparation of QC laboratories for audits and inspections
• Execution of instrument trainings including documentation of trainings
• Review of instrument logbooks and performance-documents of equipment
• Compilation of (re)qualification documents for GMP systems
• Organization and performance of (re)qualification work
• System ownership of different GMP equipment e.g., standard laboratory equipment and complex instruments
• Material receipt and sample receipt including organization of documentation
• Execution of routine QC tasks to ensure the proper working status of the laboratory e.g., calibration, cleaning and maintenance tasks

What You Need To Succeed

• Bachelor or equivalent, university degree in (bio) chemistry, biology, medical sciences, pharmacy or related field, MTA, BTA or CTA or equivalent formal education
• Experienced in the area of QC equipment qualification according to GMP guidelines
• 3-5 years of relevant experience in a pharmaceutical company as technical GMP expert
• Strong written and verbal knowledge of English
• Strong communication and organizational skills
• In-depth knowledge of instrument qualification processes
• Electronic data processing skills