Job Description

Job Purpose:

The QC Microbiology Senior Analyst will support the Bulk
Drug Facility in Dublin with emphasis on microbiological testing such as
Environmental Monitoring, Water, Gas, Bioburden and Endotoxin, technical
support with regard to method validation, regulatory updates and new
technologies.

Job Responsibilities:

   • Environmental and
Facilities monitoring sampling and testing.

   • Ensuring high
cGMP, GLP standards are maintained while testing and adherence to schedules and
targets to meet regulatory and business requirements.

  
Validation/Qualification of Microbiology test methods and test systems such as
the Endotoxin test system and Identification system.

   • Represent the
Microbiology department in internal and external audits where appropriate.

   • Close out of
actions/ recommendations identified from both internal and external audits.

   • Assist in
ensuring that current compliance issues and trends, both internal and
site-wide, are critically evaluated and training is provided where appropriate.

   • To maintain
competence and keep up to date with all new technologies, procedures and
methods used in the Microbiology Laboratory.

   • Perform technical
review of data generated in laboratory, validation protocols and reports.

     Provide Technical support to Manufacturing
and Projects which the company undertakes through project participation,
investigation, validation and testing activities and prepare Technical Reports
as required.

   • To ensure all
instruments/equipment are maintained in a calibrated and operational state.

   • 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.

   • Scheduling of
testing, review and authorization of microbial data.

   • 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.


Requirements

Experience:

   • Minimum of 3
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.