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January 20 2018

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Job Offer: QC Micro Analyst / Specialist:

Job description:

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QC Micro Analyst / Specialist

function Description


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 connected with the support of sterile manufacturing.

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 connected with the support of sterile manufacturing.

Essential tasks, Functions and The main responsibilities are:
   » 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 connected 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.
   » everyday up-keep and maintenance of Laboratory Equipment.
   » Develops and leads GMP sterility assurance training and micro consciousness 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.
expertise/expertise Required:  
 
   » practice in microbiological testing of sterile drug product and of connected environmental and utilities.
   » practice in Method Validation.
   » Good expertise of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting commercial manufacturing.
   » practice in Quality Risk Management.
Education Required:
   » Degree in Microbiology
practice Required:
   » Minimum of 5 years of practice in cGMP Quality Control Micro Laboratory environment.
 
candidates should email their cv to peter.godwin@cpl.ie or call me on 01-9476227 for a confidential conversation.

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Westmeath
Company Type Employer
Post Date: 01/12/2018 / Viewed 11 times
Contact Information
Company:
Contact Email: peter.godwin@cpl.ie


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