QA Specialist- Contamination Prevention & Control in Raron

pBe the driving force behind seamless quality assurance for a global CMO, where precision and efficiency are key to supporting world-class manufacturing. /p pProclinical is seeking a QA Specialist to support contamination prevention and control strategies within manufacturing and support units. This role focuses on premises and utilities qualification, ensuring compliance with regulatory requirements and internal quality standards. You will play a key role in maintaining facilities and utilities in a qualified and controlled state. /p pPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /p pbResponsibilities: /b /p ul liProvide quality oversight for the qualification of manufacturing facilities, including environmental monitoring and clean utility systems. /li liEnsure facilities and quality systems comply with internal standards and applicable regulations. /li liDevelop action plans to address deficiencies and maintain microbiological quality across site facilities, utilities, processes, and products. /li liAnalyze environmental monitoring data, identify trends, and implement corrective actions as needed. /li liCollaborate with cross-functional teams to meet contamination prevention requirements for new product introductions, facility changes, and process adaptations. /li liLead investigations into contamination incidents, monitoring excursions, and deviations from procedures. /li liOffer microbiological expertise to support investigations, CAPAs, and change controls related to contamination control. /li liSupport regulatory inspections and customer audits as a subject matter expert in pharmaceutical microbiology. /li /ul pbKey Skills and Requirements: /b /p ul liBachelor's degree in a relevant scientific discipline, preferably microbiology. /li liPractical knowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility systems. /li liExperience in GMP environments within the biologics industry, particularly in Quality Assurance or Quality Control Microbiology. /li liStrong understanding of contamination control principles, practices, and regulatory requirements (FDA, EMA). /li liFamiliarity with microbiological testing methods, environmental monitoring, cleanroom qualification, and microbiological control strategies. /li liExcellent written and verbal communication skills, with attention to clear and accurate documentation. /li liAbility to work effectively in a fast-paced environment, both independently and collaboratively. /li liStrong problem-solving abilities and decision-making skills. /li liA proactive mindset with the ability to prioritize tasks based on business needs. /li /ul #J-18808-Ljbffr