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QC Microbiology Analyst -

  1. Dublin
Dublin
  1. Contract
Competitive
  1. Compliance / Quality Assurance
31-01-2021
26174WP

This vacancy has now expired

QC Microbiology Analyst required for busy Biologics Bulk drug substance manufacturing facility based in Dublin 


You will be required to carry out microbiological testing such as Environmental Monitoring, Water, Gas and raw materials sampling and testing, Bioburden and Endotoxin.

Standard 40 hour week with a high chance of a shift pattern 

Duties will involve:

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

Skills Required:
  • Minimum of 1 year experience in cGMP Quality environment.
  • Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing
  • Microbiological Testing - Bioburden/Endotoxin 
  • Technical competency in Sterility Assurance, Aseptic filling and microbiology methods.
  • Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
  • Problem solving and root cause analysis skills.
  • Excellent written and oral communication skills.
 
Education:
Degree in Microbiology or related science.

Potential shift pattern would be as follows:

The shift pattern is: Week 1: Monday, Tuesday, Saturday, Sunday 7am – 7pm Week 2: Wednesday, Thursday, Friday 7am – 7pm

Call me for more information!

The candidate must have the rights to work in the location stated in the job advert.

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