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Are you fluent in German and passionate about pharmaceutical compliance? Ready to take the lead in validating cutting-edge equipment and systems that keep life-saving medicines safe?

´óÏó´«Ã½ is seeking a Senior Qualifying Specialist to support validation activities for equipment, systems, and facilities within a pharmaceutical environment. In this role, you will focus on ensuring compliance with cGMP requirements through the preparation, execution, and documentation of validation protocols. This position requires on-site work and fluency in German, with English being an added advantage.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Coordinate the installation and validation of equipment and utilities.
• Draft and execute IQ, OQ, and PQ protocols for equipment, systems, and facilities.
• Document validation results in compliance with cGMP standards.
• Prepare validation documents, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and related protocols.
• Conduct process gap analyses and risk assessments.
• Identify efficiencies in validation programs and apply lessons learned.
• Stay updated on industry regulatory changes relevant to equipment and facility validation.
• Perform quality system activities such as document management, change control, non-conformities, and CAPAs.
• Write or revise procedures related to engineering and validation activities.
• Support the engineering team in preparing requalification and maintenance programs.
• Perform other duties as assigned.

Key Skills and Requirements:

• Bachelor's degree in a science or technical field.
• Fluency in German is mandatory; English proficiency is a plus.
• Strong technical writing skills with the ability to document work thoroughly and accurately.
• Excellent organizational and time management abilities.
• Effective written and oral communication skills for cross-departmental collaboration.
• Advanced-level experience in the pharmaceutical industry.
• Ability to work 100% on-site.
  

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

´óÏó´«Ã½ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ´óÏó´«Ã½ is acting as an Employment Agency in relation to this vacancy.

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