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Microbiology Supervisor
Galway Metropolitan Area (Hybrid) · Договор
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- Опыт
- Любой
- Зарплата
- —
- Открытия
- 1
- Опубликовано
- 9 часов назад
- Режим работы
- Гибридный
- Образование
- Degree in Microbiology or related discipline
- Резюме
- Необходимо подать заявку.
Описание работы
Role Overview
Join a leading sterile manufacturing site as a Microbiology Team Lead based in Galway, Ireland, with flexible remote working options on a full-time 12-month contract. This role emphasizes leading microbiology investigations, supporting equipment qualification and automation projects, and managing microbiology professionals within a GMP environment focused on sterile pharmaceuticals and biologics.
Key Responsibilities
- Oversee microbiology investigations from start to resolution, ensuring thorough root cause analysis and impact evaluation.
- Coordinate laboratory projects and automation efforts effectively.
- Manage equipment qualification processes including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
- Collaborate with vendors, Quality Assurance, Technical Services, and Manufacturing teams.
- Organize Tier 1 operational meetings and monitor the progress of investigations and projects.
- Support compliance with Annex 1 regulations.
- Effectively prioritize workload across multiple GMP laboratory functions.
- Provide mentorship and support to microbiology technicians.
Candidate Profile
- A degree in Microbiology, Pharmaceutical Sciences, or a related scientific discipline.
- Demonstrated experience in microbiology within pharmaceutical, biopharmaceutical, or biologics manufacturing settings.
- Proven expertise in leading microbiology investigations.
- Comprehensive understanding of sterile manufacturing processes and environmental monitoring programs.
- Experience with media fill simulations and knowledge of Annex 1 requirements.
- Familiarity with GMP equipment qualification activities and documentation standards.
- Strong communication and stakeholder management capabilities.
- Skilled at balancing operational priorities with continuous improvement initiatives.
Навыки
Анализ первопричин
Координация проекта
Коммуникация с заинтересованными сторонами
Лидерство в команде
Соответствие требованиям GMP
Environmental Monitoring
Microbiology
Annex 1 Compliance
Sterile manufacturing processes
Microbiology investigations
Equipment qualification (IQ/OQ/PQ)
Media fill simulations