Senior QA Specialist

Senior QA Specialist #

(m/f/d)

Freelance/temporary employment for a project

Visp

Start date: asap

Reference number: 896900/1

Responsibilities ###

• 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

Profile ###

• 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

Benefits ###

• 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