Senior QA: Onsite Contamination Prevention & Qualification

Panda International; Oberwallis; Sur place; CHF 90 000 - 120 000; Plein temps

Résumé du poste

Panda International in Visp, Switzerland seeks a QA Specialist - Contamination Prevention & Control Senior QA Specialist on a temporary replacement. You will support 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

Qualifications

• Bachelor’s degree in a relevant scientific discipline, preferably microbiology.
• Practical knowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility systems is required.
• Substantial GMP experience in the biologics industry, with direct Quality Assurance or directly relevant Quality Control Microbiology experience.
• Strong knowledge of contamination control principles, practices, and applicable regulations, including FDA and EMA requirements.
• Working knowledge of microbiological testing methods, media challenges, environmental monitoring, cleanroom qualification and management, and microbiological control strategies.
• Excellent written and verbal communication skills, including accurate and clear documentation skills.

Responsabilités

• Provide Quality oversight for the qualification, including environmental monitoring performance qualification, of manufacturing facilities and the performance qualification of clean utility systems.
• Ensure 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.
• Analyze and interpret environmental monitoring outputs, identify trends, and implement appropriate corrective actions.
• Collaborate with cross-functional teams to ensure that contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes.
• Lead 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.
• Support regulatory inspections and customer audits as a Pharmaceutical Microbiology Subject Matter Expert.

Connaissances

Microbiology knowledge

Environmental monitoring

Documentation skills

Problem solving

Team collaboration

Decision making

Formation

Bachelor’s degree in microbiology or related

Description du poste

Panda International in Visp, Switzerland seeks a QA Specialist - Contamination Prevention & Control Senior QA Specialist on a temporary replacement. You will support 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