h3QA Specialist - Contamination Prevention Control Senior QA Specialist, Contamination Prevention Control, Temporary Replacement (m/f/d) /h3pThe 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. /ph3Key Responsibilities /h3ulliProvide 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. /liliParticipate in developing action plans to address deficiencies and ensure the appropriate microbiological quality of site facilities, utilities, processes, and products. /liliAnalyze 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. /liliProvide 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 /ulh3Key Requirements /h3ulliBachelor’s degree in a relevant scientific discipline, preferably microbiology. /liliPractical knowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility systems is required. /liliSubstantial GMP experience in the biologics industry, with direct Quality Assurance or directly relevant Quality Control Microbiology experience. /liliStrong knowledge of contamination control principles, practices, and applicable regulations, including FDA and EMA 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 /ulpPracticalities Location: Visp, Switzerland Contract Type: Contract Working Model: Onsite /p #J-18808-Ljbffr
Senior QA Specialist - Contamination Prevention & Control in Raron Arbeitgeber: Panda International
Als Arbeitgeber in der pharmazeutischen Branche bieten wir Ihnen die Möglichkeit, in einem dynamischen und internationalen Umfeld in Visp, Schweiz, zu arbeiten. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen attraktive Entwicklungsmöglichkeiten und ein wettbewerbsfähiges Gehalt von bis zu CHF 140.000 bieten. Sie werden Teil eines engagierten Teams, das an einer Vielzahl von IT-Infrastrukturprojekten arbeitet und dabei wertvolle Erfahrungen in einem regulierten Umfeld sammelt.
