Quality Assurance Specialist
ABOUT THE OPPORTUNITY
Reporting directly to the Quality Assurance Team Leader, YOU will play
an integral role in providing day to day Quality and compliance
support to the Auto-injector Assembly and Packaging area transforming
the support provided to this function.
ABOUT SANOFI BUSINESS UNIT
The multiple national award-winning Sanofi Waterford biopharmaceutical
and medical device campus is located in Waterford on Ireland&#**Apply
on the website**;s southeast coast. Established in **Apply on the
website** and now with more than **Apply on the website** employees,
the site has seen more than ?**Apply on the website**m invested in
state-of-the-art infrastructure and technology. Diversification
continues to bring new products to Waterford and the expanded site
portfolio continues to create new opportunities.
KEY RESPONSIBILITIES
The Quality Assurance Specialist has a primary role in
* Working as part of the Quality Assurance team on site assuring
products are manufactured, packaged and stored in accordance with cGMP
* Acts as Quality Point person for systems / processes providing
guidance / feedback on quality issues related to Auto-injector
Assembly & Packaging
* Perform timely review of documentation / investigations / reports
highlighting and assisting in the resolution of concerns commensurate
with the risk
* Provide Quality support for projects and technical transfers in
the Auto-injector area
* Work with relevant departments to ensure timely closure of quality
actions / findings
* Actively contribute to continuous improvement initiatives
COMPLIANCE RELATED TASKS
Ensure compliance to cGMP at all times
ABOUT YOU
To excel in this role you will need to have:-
ESSENTIAL REQUIREMENTS :
* Third Level Qualification (degree in Science or related discipline
preferred)
* Previous experience in a Quality Assurance role in a
Pharmaceutical environment
* Knowledge of Quality and cGMP in a Pharmaceutical environment
* Experienced in providing quality expertise & support to the QA
team and manufacturing. Operational experience of quality systems
(e.g. Change Control, Deviation Management, CAPA)
* Ability to support the batch release process in a dynamic
environment, ensuring delivery to timelines consistently
* Must be able to respond quickly to unplanned events, technical
issues and changing needs from development programs
* Excellent accuracy and attention to detail
* Good communication skills at organisation, team and individual
levels
IT WOULD BE ADVANTAGEOUS TO HAVE (NOT ESSENTIAL):
* Experience in a Pharmaceutical Packaging Environment (e.g. Line
clearance, Material reconciliation, Packaging specifications)
* Experienced in Packaging validation / Technical transfer processes
/ New product introduction
WHAT SANOFI CAN OFFER YOU
* A role where you are instrumental to creating best practice and as
the organisation grows, you can too.
* We offer a generous package including flexible benefits, and are
committed to helping you have a healthy work-life balance throughout
your career with us
* We have highly subsidised restaurant with free tea and coffee
* A newly refurbished gym is available onsite for a small and highly
competitive annual membership fee
* Parking available onsite
* This is a full time role and we support flexible working
ABOUT SANOFI
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases,
and consumer healthcare. This creates opportunities to work across
different areas to build a diverse and exciting career. Sanofi has the
capabilities and resources to support your aspirations to fulfill your
ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand
and solve healthcare needs of people across the world. Our ambition is
by **Apply on the website**, to be a top 3 innovative, global and
diversified human healthcare company. One that embraces transformative
technologies and is focused on its area of excellence, which means
we&#**Apply on the website**;re not there to try to solve
everybody&#**Apply on the website**;s problems. We want to focus on
those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and
integrity.
#LI-EUR
At Sanofi diversity and inclusion is foundational to how we operate
and embedded in our Core Values. We recognize to truly tap into the
richness diversity brings we must lead with inclusion and have a
workplace where those differences can thrive and be leveraged to
empower the lives of our colleagues, patients and customers. We
respect and celebrate the diversity of our people, their backgrounds
and experiences and provide equal opportunity for all.
JOB TITLE
Quality Assurance Specialist
ABOUT THE OPPORTUNITY
Reporting directly to the Quality Assurance Team Leader, YOU will play
an integral role in providing day to day Quality and compliance
support to the Auto-injector Assembly and Packaging area transforming
the support provided to this function.
ABOUT SANOFI BUSINESS UNIT
The multiple national award-winning Sanofi Waterford biopharmaceutical
and medical device campus is located in Waterford on Ireland&#**Apply
on the website**;s southeast coast. Established in **Apply on the
website** and now with more than **Apply on the website** employees,
the site has seen more than ?**Apply on the website**m invested in
state-of-the-art infrastructure and technology. Diversification
continues to bring new products to Waterford and the expanded site
portfolio continues to create new opportunities.
KEY RESPONSIBILITIES
The Quality Assurance Specialist has a primary role in
* Working as part of the Quality Assurance team on site assuring
products are manufactured, packaged and stored in accordance with cGMP
* Acts as Quality Point person for systems / processes providing
guidance / feedback on quality issues related to Auto-injector
Assembly & Packaging
* Perform timely review of documentation / investigations / reports
highlighting and assisting in the resolution of concerns commensurate
with the risk
* Provide Quality support for projects and technical transfers in
the Auto-injector area
* Work with relevant departments to ensure timely closure of quality
actions / findings
* Actively contribute to continuous improvement initiatives
COMPLIANCE RELATED TASKS
Ensure compliance to cGMP at all times
ABOUT YOU
To excel in this role you will need to have:-
ESSENTIAL REQUIREMENTS :
* Third Level Qualification (degree in Science or related discipline
preferred)
* Previous experience in a Quality Assurance role in a
Pharmaceutical environment
* Knowledge of Quality and cGMP in a Pharmaceutical environment
* Experienced in providing quality expertise & support to the QA
team and manufacturing. Operational experience of quality systems
(e.g. Change Control, Deviation Management, CAPA)
* Ability to support the batch release process in a dynamic
environment, ensuring delivery to timelines consistently
* Must be able to respond quickly to unplanned events, technical
issues and changing needs from development programs
* Excellent accuracy and attention to detail
* Good communication skills at organisation, team and individual
levels
IT WOULD BE ADVANTAGEOUS TO HAVE (NOT ESSENTIAL):
* Experience in a Pharmaceutical Packaging Environment (e.g. Line
clearance, Material reconciliation, Packaging specifications)
* Experienced in Packaging validation / Technical transfer processes
/ New product introduction
WHAT SANOFI CAN OFFER YOU
* A role where you are instrumental to creating best practice and as
the organisation grows, you can too.
* We offer a generous package including flexible benefits, and are
committed to helping you have a healthy work-life balance throughout
your career with us
* We have highly subsidised restaurant with free tea and coffee
* A newly refurbished gym is available onsite for a small and highly
competitive annual membership fee
* Parking available onsite
* This is a full time role and we support flexible working
ABOUT SANOFI
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases,
and consumer healthcare. This creates opportunities to work across
different areas to build a diverse and exciting career. Sanofi has the
capabilities and resources to support your aspirations to fulfill your
ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand
and solve healthcare needs of people across the world. Our ambition is
by **Apply on the website**, to be a top 3 innovative, global and
diversified human healthcare company. One that embraces transformative
technologies and is focused on its area of excellence, which means
we&#**Apply on the website**;re not there to try to solve
everybody&#**Apply on the website**;s problems. We want to focus on
those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and
integrity.
#LI-EUR
At Sanofi diversity and inclusion is foundational to how we operate
and embedded in our Core Values. We recognize to truly tap into the
richness diversity brings we must lead with inclusion and have a
workplace where those differences can thrive and be leveraged to
empower the lives of our colleagues, patients and customers. We
respect and celebrate the diversity of our people, their backgrounds
and experiences and provide equal opportunity for all.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
