Quality Control Micro Analyst

Posted 7 months ago

Quality Control Micro Analyst

 

The QC Microbiology Analyst will support the Bulk Drug Facility with a focus on microbiological testing such as Environmental Monitoring, Water, Gas and raw materials sampling and testing, Bioburden and Endotoxin, technical assistance regarding method validation, regulatory updates and new technology.

 

Responsibilities

  • Environmental and Facilities monitoring sampling and testing.
  • Testing to support release and stability programs on site.
  • Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
  • To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
  • Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
  • To keep management updated on issues arising within the laboratory.
  • Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
  • To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.

 

Qualifications & Education

 

  • Minimum of 1 year experience in cGMP Quality environment.
  • Experience in testing of sterile/non-sterile pharmaceutical /biopharmaceutical products.
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
  • Degree in Microbiology or related science.

 

 

To apply contact Kevin Cronin on 087 162 9928.

 

Email CVs to kcronin@mile.ie

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