QC Microbiology Specialist

Dublin  ‐ Onsite
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Keywords

Description

My client, a biotech in Dublin, is seeking a Microbiology expert to join their team.

Responsibilities:
-Expert in a wide variety of analytical techniques including: bioburden and endotoxin techniques, environmental and utilities testing, rapid micro techniques, biological indicators, sterility, growth promotion and identification techniques
-Experience of managing project groups and leading high performing teams and delivering results
-Experience with pharmaceutical Microbiological technologies and methods
-Qualification of analytical equipment and related testing functions. Prior experience in rapid micro techniques is an advantage
-Co-ordinates & plans activities related to the successful method transfers and optimisation of Microbiological Methods
-Compliance with Standard Operating Procedures and Registered specifications.
-Ensure the laboratory is operated in a safe manner
-Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP
-Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
-Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
-Approval of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.

Requirements:
This role is remunerated at the Manager level, and there requires someone with 7+ years of experience as a minimum.
-Hold a third level qualification (Degree) in Microbiology or related discipline.
-Have 7 years of experience in a pharmaceutical/healthcare Laboratory or a related technical function preferably in an Aseptic or microbiologically controlled environment.
-Strong background in microbiology and aseptic manufactured is required.
-Excellent written and verbal communication skills
-Experience with Trackwise, Change Control Systems, EDMQ and SAP an advantage Knowledge of applicable Regulatory requirements
-Experience with Regulatory inspections and interacting with inspectors.

If you are interested in this great opportunity and have the relevant skill set and experience please contact me Anna Mooney or apply below with an up to date CV.

Sthree UK is acting as an Employment Agency in relation to this vacancy.
Start date
01/2014
From
Real Staffing
Published at
01.02.2014
Project ID:
659388
Contract type
Permanent
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