Senior QA Specialist
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Job description
# 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
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