Senior QA Specialist - Maternity Cover - 7122 in Raron

pCTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed. /p pOur client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a bSenior QA Specialist - Maternity cover, /b based in bVisp /b, bSwitzerland /b for ba 7 months contract, with the possibility of extension. /b /p pThe position will support the end-to-end contamination control strategies within our site manufacturing and support units and will be responsible for Premises and Utilities Qualification within Contamination Prevention Control. The Senior QA Specialist ensures that qualification activities meet applicable regulatory requirements and internal quality standards and support the continued maintenance of facilities and utilities in a qualified and controlled state. /p h3Main responsibilities: /h3 ulliProvide Quality oversight for the qualification, including environmental monitoring performance qualification, of manufacturing facilities and the performance qualification of clean utility systems. /liliEnsure that facilities and quality systems remain compliant with internal requirements and applicable regulations. Participate in developing action plans to address deficiencies and ensure the appropriate microbiological quality of site facilities, utilities, processes, and products. /liliAnalyse and interpret environmental monitoring outputs, identify trends, and implement appropriate corrective actions. /liliCollaborate with cross-functional teams to ensure that contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes. /liliLead and guide investigations into monitoring excursions, contamination incidents, and deviations from contamination control procedures. Provide microbiological expertise to support investigations, CAPAs, and change controls related to contamination prevention and control. /liliSupport regulatory inspections and customer audits as a Pharmaceutical Microbiology Subject Matter Expert. /li /ul h3Required Qualifications /h3 ullibRelevant Swiss working/residency permit and/or Swiss/EU-Citizenship required; /b /liliBachelor’s degree in a relevant scientific discipline, preferably microbiology. /liliPractical bknowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility /b systems is required. /liliSubstantial bGMP /b experience in the biologics industry, with direct bQuality Assurance /b or directly relevant bQuality Control Microbiology /b experience. /liliStrong knowledge of bcontamination control principles /b, practices, and applicable regulations, including bFDA and EMA /b requirements. /liliWorking knowledge of microbiological testing methods, media challenges, environmental monitoring, cleanroom qualification and management, and microbiological control strategies. /liliExcellent written and verbal communication skills, including accurate and clear documentation skills. /liliAbility to work effectively in a fast-paced environment, both independently and as part of a team, with a strong work ethic. /liliStrong problem-solving mindset and sound decision-making skills. /liliStrong sense of ownership and the ability to prioritize activities based on business needs. /li /ul #J-18808-Ljbffr