Microbiologist Quality Control Specialist

5 days ago

Dublin, Dublin City, Ireland beBeeMicrobiologist Full time €75,000 - €95,000

Team Horizon is seeking a skilled Microbiologist to join their team in Dublin. This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

About the Role
  • This is an excellent opportunity to work in a world-class manufacturing operation, with a strong track record of delivering high-quality medicines to patients around the world suffering from serious illnesses.
  • The company has a culture of continuous improvement and innovation, striving for solutions that improve health outcomes and dramatically improve people's lives.
Key Responsibilities
  1. Environmental Monitoring: Ensure accurate and timely monitoring of environmental conditions within Grade 8/9 Cleanrooms.
  2. Cleanroom Monitoring: Conduct regular monitoring to maintain aseptic conditions in Grade 5/7 Cleanrooms & Isolators.
  3. Data Analysis: Analyze data to identify trends and make recommendations.
  4. Quality Control: Conduct bioburden testing of water & disinfectants to ensure compliance with quality standards.
  5. Technical Reporting: Communicate results and findings effectively through technical reports.
  6. Water Sampling: Collect and analyze water samples to ensure quality standards.
  7. In-Process Testing: Conduct analytical tests on in-process samples such as Density & pH to ensure product quality.
  8. Scientific Expertise: Apply scientific knowledge to ensure product quality and safety, backed by a strong background in microbiology and aseptic manufacturing.
  9. Software Proficiency: Utilize software systems such as LIMS, Change Control, Trackwise, SAP and CDOCS to streamline processes and improve efficiency.
  10. Flexibility: Adapt to changing priorities on a daily basis.
  11. Leadership and Communication: Effectively communicate with colleagues and management, demonstrating leadership skills.
  12. Auditing and Compliance: Review and assess processes to ensure compliance with regulatory requirements.
  13. Regulatory Collaboration: Collaborate with regulatory agencies to ensure compliance.
Requirements
  • Education: Possess a Bachelor's degree in a science discipline, providing a strong foundation in scientific principles.
  • Experience: Bring experience in biopharmaceutical QC in a microbiology lab, applying knowledge and skills gained in previous roles.
  • Regulatory Knowledge: Have experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products, ensuring adherence to industry standards.
  • Aseptic Cleanroom Experience: Have experience working in an aseptic cleanroom performing Environmental Monitoring, applying technical skills in a controlled environment.
  • Software Skills: Be proficient in the use of LIMS & LMES, utilizing software systems effectively.

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