Qc Micro Analyst

5 days ago

Dublin, Dublin City, Ireland Pe Global Full time

PE Global is currently recruiting for a QC Micro Analyst on behalf of our client based in North Dublin: Full Time 8 Month Contract Reporting to the QC Microbiology Manger, the QC Microbiology Analyst will be responsible for supporting site activities related to Product Testing a, performing testing of samples and laboratory duties in accordance with cGMP regulations.
Responsibilities will include (but not limited to): Performing bioburden testing on utility samples, drug substance and raw materials within the required hold times.
Performing bacterial endotoxin testing on utility samples, drug substance and drug product within the required hold times.
Carrying out the Minute Mouse Virus (MMV) by PCR and quantitative PCR (qPCR) testing of in-process samples.
Perform compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.
Performing growth promotion testing of media and organism lots entering the laboratory.
Performing microbial identifications using MALDI-TOF and MicroSEQ.
Completing all laboratory documentation in a timely and accurate manner.
Compliance with Standard Operating Procedures and Registered Specifications.
Assisting in authoring and reviewing documentation, including SOPs.
Providing support to other departments to ensure qualification and production schedules are adhered to.
Reviewing Batch paperwork, and reconciliation of analysis performed in the laboratory.
Ensuring that any alert/action limit excursions are investigated according to site procedures.
Ensuring a high standard of housekeeping and safety is maintained in the laboratory.
Performing any other activities as indicated by the Microbiology Manager.
Qualifications and Experience required: The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
At least 1 years experience in a pharmaceutical / healthcare laboratory or related technical function.
A strong background in Microbiology and aseptic manufacturing is desirable but not essential.
The successful candidate must demonstrate excellent written and verbal communication skills.
The ability to work in a team based collaborative environment is essential.
Note: This candidate may be required to work a 12/7 shift pattern.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on or alternatively send an up-to-date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application.
You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you.
You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy.
Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.
Skills: microbiology aseptic manufacturing bioburden

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