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January 20 2018

    Job details

Offer: QC MICRO ANALYST / SPECIALIST:CPL

Job description:


   » Job ID.:15312229
   » Employer ID.:RI/JO-1711-364198_3
   » Published:12-JAN-2018
   » income:NEGOTIABLE
   » Job location:WESTMEATH
   » Employment Type:PERMANENT

 

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.
This job originally appeared on RecruitIreland.com

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 12 times
Contact Information
Company: CPL
Contact Email: peter.godwin@cpl.ie


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