We have an exciting opening on our client?s manufacturing facility
in Dublin. In this role, you will be responsible for conducting raw
material, in process, finished product, and where applicable stability
testing.
_YOU WILL_ have the opportunity to identify and troubleshoot issues
related to laboratory testing and equipment so you will have to have
an in-depth knowledge of scientific methods and techniques.
Why you should apply:
?
* Our client has developed a stand-out culture of innovation,
inclusion and development, and consistently features as a great place
to work.
?
* The role is generously compensated, and attracts a competitive base
salary and highly attractive benefits package.
?
* Excellent career progression opportunities.
What you will be doing:
?
* You will conduct chemical and physical laboratory tests and analyze
raw materials, intermediates and final product to ensure compliance
with standards.
?
* Complete all testing, including special project / protocol testing
in a timely manner that supports established production targets and
SLAs.
?
* Maintain data integrity and ensure compliance with FDA, GLP, QSR and
cGMP regulations, as well as with company SOPs and specifications.
?
* Observe established escalation process for laboratory issues that
impact established production-related Service Level Agreements (SLAs)
and/or the fulfillment of production goals.
?
* Participate in deviation investigations.
?
* Author documents that ensure cGMP compliance, such as laboratory
investigation, deviations, change controls, change notices, analytical
test methods; analytical test method development reports; method
validation protocols; method transfer protocols and reports; method
verifications protocols and reports; and instrumentation qualification
documentation (URS/IQ/OQ/PQ).
?
* Seek process innovation and continuous process improvement and
perform quality improvement initiatives in the laboratory to meet site
production goals.
?
* Support and adhere to established processes and productivity targets
while recognizing and reporting any issues or deviations from accepted
standards to your supervisor
?
* Provide status updates on own activities and productivity challenges
according to defined procedures.
What you need to apply:
?
* A third level qualification in Chemistry or related Science,
preferably a Bachelor?s Degree
?
* **Apply on the website** ? **Apply on the website** months minimum
relevant Quality Control experience or equivalent combination of
education and experience (**Apply on the website** years).
?
* Experience in pharmaceutical manufacturing facility.
?
* Knowledge of cGMP requirements and practices including extensive
knowledge of the USP and FDA Guidance Documents relating to the
pharmaceutical Quality Control Laboratory.
?
* Experience in HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME),
UV/Vis and other USP instrumental and Wet chemistry technologies used
in pharmaceutical Quality Control Laboratory.
?
* Strong analytical laboratory skills and laboratory troubleshooting
abilities.
?
* Success in making effective and persuasive presentations on complex
topics to upper management.
?
* Experience with chromatographic software packages e.g. Empower QC Chemist ? Team Horizon
We have an exciting opening on our client?s manufacturing facility
in Dublin. In this role, you will be responsible for conducting raw
material, in process, finished product, and where applicable stability
testing.
_YOU WILL_ have the opportunity to identify and troubleshoot issues
related to laboratory testing and equipment so you will have to have
an in-depth knowledge of scientific methods and techniques.
Why you should apply:
?
* Our client has developed a stand-out culture of innovation,
inclusion and development, and consistently features as a great place
to work.
?
* The role is generously compensated, and attracts a competitive base
salary and highly attractive benefits package.
?
* Excellent career progression opportunities.
What you will be doing:
?
* You will conduct chemical and physical laboratory tests and analyze
raw materials, intermediates and final product to ensure compliance
with standards.
?
* Complete all testing, including special project / protocol testing
in a timely manner that supports established production targets and
SLAs.
?
* Maintain data integrity and ensure compliance with FDA, GLP, QSR and
cGMP regulations, as well as with company SOPs and specifications.
?
* Observe established escalation process for laboratory issues that
impact established production-related Service Level Agreements (SLAs)
and/or the fulfillment of production goals.
?
* Participate in deviation investigations.
?
* Author documents that ensure cGMP compliance, such as laboratory
investigation, deviations, change controls, change notices, analytical
test methods; analytical test method development reports; method
validation protocols; method transfer protocols and reports; method
verifications protocols and reports; and instrumentation qualification
documentation (URS/IQ/OQ/PQ).
?
* Seek process innovation and continuous process improvement and
perform quality improvement initiatives in the laboratory to meet site
production goals.
?
* Support and adhere to established processes and productivity targets
while recognizing and reporting any issues or deviations from accepted
standards to your supervisor
?
* Provide status updates on own activities and productivity challenges
according to defined procedures.
What you need to apply:
?
* A third level qualification in Chemistry or related Science,
preferably a Bachelor?s Degree
?
* **Apply on the website** ? **Apply on the website** months minimum
relevant Quality Control experience or equivalent combination of
education and experience (**Apply on the website** years).
?
* Experience in pharmaceutical manufacturing facility.
?
* Knowledge of cGMP requirements and practices including extensive
knowledge of the USP and FDA Guidance Documents relating to the
pharmaceutical Quality Control Laboratory.
?
* Experience in HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME),
UV/Vis and other USP instrumental and Wet chemistry technologies used
in pharmaceutical Quality Control Laboratory.
?
* Strong analytical laboratory skills and laboratory troubleshooting
abilities.
?
* Success in making effective and persuasive presentations on complex
topics to upper management.
?
* Experience with chromatographic software packages e.g. Empower
We need : English (Good)
Type: Permanent
Payment:
Category: Others