QA SME Environmental & Sterile practices

Manage and maintain the Environmental & Sterile practices programme in line with regulatory requirements. Ensure compliance with EU GMP Annex 1, FDA guidance, ISO standards, and contamination control strategies. Review and trend environmental monitoring data to identify risks and improvement opportunities. Establish and maintain alert/action limits and monitoring strategies based on risk assessments. Support investigations, deviations, and CAPA related to environmental and personnel excursions. Support aseptic process simulations, personnel qualification, and contamination control training. Ensure data integrity, accurate documentation, and inspection readiness. Drive continuous improvement of environmental controls and contamination prevention practices. Qualification Bachelor’s degree or National diploma in Microbiology, Biotechnology, Pharmacy, or related Life Sciences Certifications in GMP, Quality Systems, or Sterility Assurance advantageous Experience 10 - 15 years in pharmaceutical, microbiology or quality Minimum 10 years in sterile manufacturing environment Proven experience with environmental/personnel monitoring programs and sterile practices. Experience in regulatory inspections