- ?**Apply on the website** - ?**Apply on the website** Joining b
* Biopharmaceutical Data Review Scientist - Athlone, Ireland
* * Remote working ?**Apply on the website** - ?**Apply on the
website** Joining Bonus
* We are vital links between an idea for a new medicine and the people
who need it. We are the people of PPD - thousands of employees in
locations worldwide connected by tenacity and passion for our purpose:
to improve health .
_YOU WILL_ be joining a truly collaborative and winning culture as we
strive to bend the time and cost curve of delivering life-saving
therapies to patients.
Our GMP laboratory based in Athlone, Ireland offers fully integrated
solutions for product development and analytical development,
including analytical testing services in method development, method
validation, method transfer, release and stability studies. Our highly
qualified GMP lab staff work across our 3 laboratory groups:
Biopharm, Small Molecule, and Inhalation.
We are currently seeking a Data Review scientist to join our growing
team, this position once onboarded will be remote enabled:
* KEY RESPONSIBILITIES:
* * Ensures the quality of laboratory data and reports.
* Evaluates data to ensure compliance with analytical methods, client
criteria, and Good Manufacturing Practices (GMP).
* Performs Rel ease, Stability, non-routine and complex analytical
data reviews ensuring scientific soundness and method validation.
* Reviews chromatographic/electrophoretic data and related
documentation as specified by Standard Operating Procedures (SOPs).
* Reviews sample results tables and analytical reports for
completeness and accurate representation of the data and report
findings.
* Communicates with laboratory staff to proactively address the
quality of laboratory documentation.
* Prepares statements noting deficiencies with the analytical data set
or documentation.
* Reports deficiencies to the project leader for correction.
* Trains new data Reviewers and laboratory staff. Performs other
duties as assigned, including SOP review and writing.
* Conducts consultations for quality records.
* QUALIFICATIONS:
* * Education and experience
* * BSc in Science or related field required
* 2+ years of QA/QC experience required (gaining thorough knowledge of
chromatography, and ideally also knowledge of electrophoresis, ELISA,
compendial tests)
* Thorough knowledge of SOPs and FDA, EMA Regulations to include GMP
* Strong verbal and written communication skills
* Strong technical knowledge including an understanding of laboratory
procedures, methodology and standards
* Ability to independently review laboratory reports and analytical
methods
* Strong attention to detail
* Ability to provide clear and concise feedback and/or documentation
of results
As well as being rewarded a competitive salary, we have an extensive
benefits package based around the health and well-being of our
employees. We have a flexible working culture , where PPD truly value
a work-life balance. We&#**Apply on the website**;ve grown sustainably
year on year but continue to offer a collaborative environment, with
teams of colleagues eager to share expertise and have fun together.
We are a global organisation but with a local feel.
* Joining Bonus
* Pension scheme
* Annual Leave **Apply on the website** days
* Medical Health care cover
* Life Insurance
* We have a strong will to win - We earn our customer&#**Apply on the
website**;s trust - We are gamechangers - We do the right thing
-We are one PPD ** - **
* If you resonate with our five principles above, and ultimately wish
to accelerate the delivery of safe and effective therapeutics for some
of the world&#**Apply on the website**;s most urgent health needs,
then please submit your application - we&#**Apply on the website**;d
love to hear from you. 1
As we are likely to receive many applications, sometimes we are unable
to provide feedback to everyone.
#LI-MG1 G1
#LI-MG1 Position: ?Biopharmaceutical Data Review Scientist ?Remote working
- ?**Apply on the website** - ?**Apply on the website** Joining b
* Biopharmaceutical Data Review Scientist - Athlone, Ireland
* * Remote working ?**Apply on the website** - ?**Apply on the
website** Joining Bonus
* We are vital links between an idea for a new medicine and the people
who need it. We are the people of PPD - thousands of employees in
locations worldwide connected by tenacity and passion for our purpose:
to improve health .
_YOU WILL_ be joining a truly collaborative and winning culture as we
strive to bend the time and cost curve of delivering life-saving
therapies to patients.
Our GMP laboratory based in Athlone, Ireland offers fully integrated
solutions for product development and analytical development,
including analytical testing services in method development, method
validation, method transfer, release and stability studies. Our highly
qualified GMP lab staff work across our 3 laboratory groups:
Biopharm, Small Molecule, and Inhalation.
We are currently seeking a Data Review scientist to join our growing
team, this position once onboarded will be remote enabled:
* KEY RESPONSIBILITIES:
* * Ensures the quality of laboratory data and reports.
* Evaluates data to ensure compliance with analytical methods, client
criteria, and Good Manufacturing Practices (GMP).
* Performs Rel ease, Stability, non-routine and complex analytical
data reviews ensuring scientific soundness and method validation.
* Reviews chromatographic/electrophoretic data and related
documentation as specified by Standard Operating Procedures (SOPs).
* Reviews sample results tables and analytical reports for
completeness and accurate representation of the data and report
findings.
* Communicates with laboratory staff to proactively address the
quality of laboratory documentation.
* Prepares statements noting deficiencies with the analytical data set
or documentation.
* Reports deficiencies to the project leader for correction.
* Trains new data Reviewers and laboratory staff. Performs other
duties as assigned, including SOP review and writing.
* Conducts consultations for quality records.
* QUALIFICATIONS:
* * Education and experience
* * BSc in Science or related field required
* 2+ years of QA/QC experience required (gaining thorough knowledge of
chromatography, and ideally also knowledge of electrophoresis, ELISA,
compendial tests)
* Thorough knowledge of SOPs and FDA, EMA Regulations to include GMP
* Strong verbal and written communication skills
* Strong technical knowledge including an understanding of laboratory
procedures, methodology and standards
* Ability to independently review laboratory reports and analytical
methods
* Strong attention to detail
* Ability to provide clear and concise feedback and/or documentation
of results
As well as being rewarded a competitive salary, we have an extensive
benefits package based around the health and well-being of our
employees. We have a flexible working culture , where PPD truly value
a work-life balance. We&#**Apply on the website**;ve grown sustainably
year on year but continue to offer a collaborative environment, with
teams of colleagues eager to share expertise and have fun together.
We are a global organisation but with a local feel.
* Joining Bonus
* Pension scheme
* Annual Leave **Apply on the website** days
* Medical Health care cover
* Life Insurance
* We have a strong will to win - We earn our customer&#**Apply on the
website**;s trust - We are gamechangers - We do the right thing
-We are one PPD ** - **
* If you resonate with our five principles above, and ultimately wish
to accelerate the delivery of safe and effective therapeutics for some
of the world&#**Apply on the website**;s most urgent health needs,
then please submit your application - we&#**Apply on the website**;d
love to hear from you. 1
As we are likely to receive many applications, sometimes we are unable
to provide feedback to everyone.
#LI-MG1 G1
#LI-MG1
We need : English (Good)
Type: Permanent
Payment:
Category: Others
