Job Details: QCAT Analyst/Microbiology


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QCAT Analyst/Microbiology
 Our client is a world leader in developing and commercializing
innovative biopharmaceuticals for rare diseases driven by genetic
causes.  They have a superb opportunity for a  QCAT Analyst
(Microbiology) based in Cork.

KEY RESPONSIBILITIES:

? Develop, optimize, validate and troubleshoot microbiological test
methods

? Prepare protocols, summaries, and reports-often for direct
submission to pharmaceutical regulatory agencies

? Review QC raw data and trend results

? Microbiological testing performed by the lab incl: endotoxin,
bioburden, sterility, rapid methods etc

? Testing of in-process, bulk drug substance, finished product, raw
materials, packaging

? Prepare protocols, summaries, and reports-often for direct
submission to pharmaceutical regulatory agencies

? Draft QC SOPs

? Act as a technical resource (SME) and train other analysts in areas
of expertise

? Evaluate results against defined acceptance criteria

? Conduct and document laboratory investigations to completion

? Maintain the laboratory in an inspection-ready state

? Interact directly with regulatory agency inspectors during audits

KEY REQUIREMENTS:

? B.S. in a scientific discipline

? 3+ years working in a GMP lab

? Bioburden experience

? Excellent verbal and written communication skills

PREFERRED REQUIREMENTS:

? Pharmaceutical experience

? Sterility and endotoxin

? Validation protocols

? Training of staff members

Fastnet has a strict confidentiality policy - please be assured that
your details will never be forwarded to any third party without your
consent.

FASTNET - THE TALENT GROUP

_&#**Apply on the website**;Not Just Placers.........Partners&#**Apply
on the website**;_

The Life Science Specialists
     Our client is a world leader in developing and commercializing
innovative biopharmaceuticals for rare diseases driven by genetic
causes.  They have a superb opportunity for a  QCAT Analyst
(Microbiology) based in Cork.

KEY RESPONSIBILITIES:

? Develop, optimize, validate and troubleshoot microbiological test
methods

? Prepare protocols, summaries, and reports-often for direct
submission to pharmaceutical regulatory agencies

? Review QC raw data and trend results

? Microbiological testing performed by the lab incl: endotoxin,
bioburden, sterility, rapid methods etc

? Testing of in-process, bulk drug substance, finished product, raw
materials, packaging

? Prepare protocols, summaries, and reports-often for direct
submission to pharmaceutical regulatory agencies

? Draft QC SOPs

? Act as a technical resource (SME) and train other analysts in areas
of expertise

? Evaluate results against defined acceptance criteria

? Conduct and document laboratory investigations to completion

? Maintain the laboratory in an inspection-ready state

? Interact directly with regulatory agency inspectors during audits

KEY REQUIREMENTS:

? B.S. in a scientific discipline

? 3+ years working in a GMP lab

? Bioburden experience

? Excellent verbal and written communication skills

PREFERRED REQUIREMENTS:

? Pharmaceutical experience

? Sterility and endotoxin

? Validation protocols

? Training of staff members

Fastnet has a strict confidentiality policy - please be assured that
your details will never be forwarded to any third party without your
consent.

FASTNET - THE TALENT GROUP

_&#**Apply on the website**;Not Just Placers.........Partners&#**Apply
on the website**;_

The Life Science Specialists
    

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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