Senior QA Specialist (m/f/d)

Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.

• Provide quality oversight for the qualification of manufacturing facilities, cleanrooms, and clean utility systems
• Support environmental monitoring performance qualification activities and ensure compliance with GMP requirements
• Review, analyze, and trend environmental monitoring data to identify potential risks and improvement opportunities
• Ensure facilities, utilities, and related quality systems remain in a qualified and compliant state
• Lead investigations of contamination events, monitoring excursions, and quality deviations
• Support the implementation of corrective and preventive actions (CAPAs) related to contamination control
• Collaborate with Manufacturing, Engineering, Validation, QC, and other cross-functional teams on facility and process changes
• Provide microbiological expertise for change controls, risk assessments, and new product introductions
• Support regulatory inspections and customer audits as a subject matter expert in pharmaceutical microbiology
• Contribute to the continuous improvement of contamination prevention and control strategies across the site

• Bachelor's degree in Microbiology, Biotechnology, Life Sciences, or a related scientific discipline
• Solid experience in GMP-regulated pharmaceutical or biologics manufacturing environments
• Strong knowledge of contamination control principles and microbiological quality requirements
• Hands-on experience with cleanroom qualification, environmental monitoring, and clean utility systems
• Experience supporting or leading investigations, deviations, CAPAs, and change controls
• Good understanding of FDA, EMA, and other applicable GMP regulations
• Familiarity with microbiological testing methods and monitoring programs
• Strong analytical and problem-solving skills
• Excellent communication and documentation skills in a regulated environment
• Ability to work independently while effectively collaborating with cross-functional stakeholders

• Opportunity to contribute to quality and patient safety within a leading biotechnology environment
• Exposure to complex contamination control and facility qualification projects
• Cross-functional collaboration with Quality, Manufacturing, Engineering, and Validation teams
• Dynamic and highly regulated GMP environment with diverse responsibilities
• Opportunity to act as a subject matter expert in microbiology and contamination control
• Involvement in regulatory inspections and customer audits
• Professional development within a quality-focused organization
• International and collaborative working environment
• Meaningful role supporting operational excellence and compliance

Ihr Kontakt

Referenznummer
896900/1

Kontakt aufnehmen
Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch

Anstellungsart
Freiberuflich für ein Projekt