Senior QA Specialist - Contamination Control (6-mo)

CTC Resourcing Solutions; Oberwallis; Sur place; CHF 90 000 - 120 000; Plein temps

Résumé du poste

CTC Resourcing Solutions supports a global market leader in Visp, Switzerland, by recruiting a Senior QA Specialist for a 7-month maternity cover. The role centers on end-to-end contamination control, facilities and utilities qualification, and maintaining compliant quality systems in manufacturing environments.

The candidate brings GMP expertise, microbiology knowledge, and strong regulatory proficiency (FDA/EMA), with excellent documentation skills and the ability to lead investigations and

Qualifications

• Bachelor’s degree in a relevant scientific discipline, preferably microbiology.
• Knowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility systems.
• GMP experience in biologics with QA or QC microbiology background.
• Familiarity with FDA and EMA requirements.
• Strong written and verbal communication and documentation skills.

Responsabilités

• Provide QA 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.
• Analyse 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

GMP experience

Quality Assurance

Quality Control Microbiology

Environmental monitoring

Contamination control

Manufacturing facilities qualification

Regulatory knowledge (FDA/EMA)

Documentation

Team collaboration

Problem-solving

Formation

Bachelor’s degree in microbiology

Description du poste

CTC Resourcing Solutions supports a global market leader in Visp, Switzerland, by recruiting a Senior QA Specialist for a 7-month maternity cover. The role centers on end-to-end contamination control, facilities and utilities qualification, and maintaining compliant quality systems in manufacturing environments.

The candidate brings GMP expertise, microbiology knowledge, and strong regulatory proficiency (FDA/EMA), with excellent documentation skills and the ability to lead investigations and