Lead Analyst Microbiology

PE Global is currently recruiting for a Lead Analyst Microbiology for a leading multi-national client based in Carlow.

This is a permanent position.

Responsibilities:

Work with the PSS Manager to effectively coordinate and lead the PSS team so that productivity, quality, documentation, work schedules, safety and housekeeping are run at maximum efficiency.
Ensuring that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
Set up a laboratory including drafting general standard operating procedures (SOP’s)and Micro specific SOPs
Work with Operations, Quality Assurance, and the Projects team on authoring qualification protocols
Oversee vendor qualification of equipment and manage equipment Performance Qualification projects
Manage Method qualification, method transfer and method verification for sterility, Bioburden and endotoxin and new product introduction
Review and QC release of laboratory reagents including biological indicators, microbiological cultures, media and endotoxin challenge vials
Provide support and subject matter expert knowledge in investigations associated with deviations
Notify the client representative, any anomalous or out of specification results and participate in the investigation as appropriate.
Developing training materials and delivering training to other team members as required. Ensuring all training delivered is documented appropriately.

Requirements:

Experience / Skills

A minimum of 4 years’ relevant experience of Microbiology within a GMP environment
At least 1 years’ experience in a supervisory/leadership capacity is an advantage
Subject Matter Expert in applicable microbiological tests (Sterility, Endotoxin, Bioburden and method qualifications.
Laboratory Quality Systems, GLIMS and SAP

Full understanding of requirements for working in a GMP environment

Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh McDonald on +353 21 4520313 or alternatively send an up-to-date CV to Niamh.mcdonald@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***