Überspringen

QA Senior Specialist Environmental Monitoring

Temporär in Umweltschutz und Umweltingenieurswesen

Job-Beschrieb

QA Senior Specialist Environmental Monitoring

m/f/d, Wallis

We are looking for a QA Senior Specialist Environmental Monitoring who will provide Quality oversight for the qualification (environmental monitoring PQ) of manufacturing facilities and PQ of clean utilities systems

This is a temporary contract until 21.12.2024

Responsibilties

  • Ensure facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participate in developing action plans to correct deficiencies and ensure the adequate microbiological quality of the site facilities, utilities, processes, and products.
  • Analyze and interpret environmental monitoring data, identify trends, and implement adequate corrective actions.
  • Collaborate with cross-functional teams to ensure contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes.
  • Lead and guide Investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures. Provide microbiological expertise to support Investigations, CAPAs, and Change Control related to Contamination Prevention and Control.
  • Develop and deliver training programs to facility staff on contamination prevention and control, Cleanroom behavior, and hygiene best practices.
  • Supports regulatory inspections and customer audits as a Pharmaceutical Microbiology subject matter expert.

Requirements:

  • Bachelor’s degree in a relevant scientific discipline (preferably in microbiology).
  • Substantial GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience.
  • Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA).
  • Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbiological control strategy required.
  • Fluency in English, German nice to have.

Sounds like a great job?
Then we look forward to receiving your complete application documents through our online application form.

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Find more vacancies at: coopers.ch

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Agnieszka Kawalec
Talent Acquisition Consultant
+41 41 632 43 54
Agnieszka.Kawalec@coopers.ch