Cache of job #13986933

Job Title

Plant Microbiologist

Employer

Pe Global

Location

Dublin West, Dublin West

Description

PE Global are currently recruiting for a Plant Microbiologist for one of our global Pharmaceutical clients based in Dublin. This is a permanent role. The purpose of the role is to manage the Microbiology laboratory to support the aseptic manufacturing of certain products at the plant. Responsibilities: Responsible for the overall management of the Microbiology laboratory supporting the manufacture of particular products. Provide technical support for the qualification and validation of the manufacturing facility. Establish and lead the Microbiology team supporting the technical transfer of products through to operation readiness: Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation. Responsible for the Microbiology Laboratory Start-up activities which includes development of URSs, Risk Assessments, Protocols, Reports, SOPs, EOPs work instructions, procurement and qualification of equipment, software and utilities/facilities. Responsible for the operation and inspection readiness of the Microbiology laboratory by ensuring the laboratory operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times. Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations. Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples. People manager responsible for recruiting, managing, training, development and performance reviews from project phase into sustaining production. Manage the environmental monitoring to support the manufacturing of products. Lead and participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing. Manage contract testing laboratories associated with microbiological testing. Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP. Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer. Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas. Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times. Generate, implement and control of Microbiology annual budget for consumables, capital and headcount. Requirements. Degree in Microbiology or other relevant field. 5+ years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company. Extensive experience of microbiology testing including Contamination Control. Sterility, endotoxin, mycoplasma and Environmental Management. Thorough knowledge of GMP and current FDA & EMEA regulations. Knowledge and experience of Lean Laboratories is preferable. Previous experience managing the performance of individual team members and the overall team. If you are interested in this position, please forward your CV to tina.dorgan@peglobal.net or call 0214297900 . Alternatively please feel free to connect with me on LinkedIn. 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. This job originally appeared on RecruitIreland.com.

Date Added

1891 days ago

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