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