Posted: 18 June
The role
PE Global is currently recruiting for a Senior QC Microbiologist for a leading multi-national Pharma client based in South Dublin.
This is a contract position.
Role
Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.
Responsibilities
Endotoxin testing of water, in-process and drug product release samples
Bioburden testing of water & in-process drug product samples
Sterility testing
Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
Writing technical reports
Media fill reconciliation and inspection
Perform analytical testing as a main priority with efficiency and accuracy
With a high degree of technical flexibility, work across diverse areas within the lab
Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
Report, evaluate, archive, trend and approve analytical data.
Troubleshoot, solve problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents.
Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
Write protocols and perform assay validation.
Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
Review and Approve lab results
May participate in lab investigations.
May provide technical guidance.
May train others.
May contribute to regulatory filings.
May represent the department/organization on various teams
May interact with outside resources
Requirements
Biopharmaceutical QC experience in a microbiology lab
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
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