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Employer CPL
Job Title QC Micro Analyst
Description

QC Micro Analyst- US Pharma Start up- Westmeath

My client, a clinical- stage pharmaceutical company, are looking for QC Micro Analyst to perform environmental monitoring, water testing, microbial testing of raw materials and in process samples.

The Job

Overall Purpose: QC Micro Analyst performs environmental monitoring, water testing, microbial testing of raw materials and in process samples. The QC Micro Analyst will be responsible for the execution of validation/qualification protocols. The QC Microbiology Analyst is required to work in a GMP environment meeting all expectations associated with the support of sterile manufacturing.

Essential Duties, Functions and Responsibilities:

  • Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety and is diligent in the use of all appropriate safety tools, PPE and permits when sampling or when testing in the laboratory. Maintains a high standard of housekeeping within the Laboratory.
  • Performs environmental monitoring, water testing and associated microbial testing including
endotoxin, bioburden testing, TOC/conductivity testing, growth promotions, bacterial identification and biological indicator testing.

  • Actively participates and can lead laboratory investigations using structured problem solving processes.
  • Develops lab procedures and supports site procedure development as required.
  • Executes validation protocols for process validation and method validation.
  • Reviews laboratory data and documentation as assigned.
  • Daily up-keep and maintenance of Laboratory Equipment.
    • Develops and leads GMP sterility assurance training and micro awareness training to site personnel.
    • Participates in bi-annual media fill studies to maintain line qualification status.
    • Is diligent in the completion and review of batch and testing documentation required to meet cGMP requirements. Accuracy and timely recording of all GMP information is particularly importance in a GMP laboratory.
      • Is always prepared to escalate any safety, quality or performance risk observed.
Skills/Knowledge Required:

  • Experience in microbiological testing of sterile drug product and of associated environmental and utilities.
  • Experience in Method Validation.
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting commercial manufacturing.
  • Experience in Quality Risk Management.
Education Required :

  • Degree in Microbiology
Experience Required:

  • Minimum of 5 years of experience in cGMP Quality Control Micro Laboratory environment.

Applicants should email their cv to peter.godwin@cpl.ie or call me on 01-9476227 for a confidential conversation.

This job originally appeared on RecruitIreland.com
Location Westmeath
Date Added 20 days ago
Apply Link
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