in our Dublin office.
These are Permanent positions.
Job Purpose
The Batch Release Specialist prepares product release dossiers for
presentation to the EU / UK QP Hub QPs. This involves reviewing batch
deviations, transit temperature control devices, sampling plan and
test results. It includes following up with the manufacturing sites
and Logistics groups on issues that arise from the reviews to support
batch certification processes.
The scope of this role includes support to GSK Trading Services, GSK
Export Ltd, Consumer Trading Services and ViiV Trading Services, and
may be expanded to support other entities if created. The EU / UK QP
Hub manages approximately **Apply on the website** batches per annum
and this role is key to ensuring compliant release of batches.
As Batch Release Specialist, you will be responsible for:
Liaise with Principal Trading Companies (PTC) and other groups for
co-ordination of batch release scheduling for products imported into
Europe
Prepare batch release dossiers for presentation to the QP in support
of compliant batch release and timely escalation of any issues
identified
Review associated records and documentation, including deviations and
liaise with the manufacturing site and QP to understand the impact of
the deviation on product quality prior to release ? manage
correspondence and communication between the parties to conclusion.
Raise and track iCargo deviations for transit temperature excursions,
liaising with the Pharma Logistics group and supplying sites to
resolve and close, ensuring escalation to the QPs.
Raise and investigate deviations relating to importation activities
Conduct activities to support EU / UK QP Hub processes related to
quality oversight for importation, including;
Quality meetings
Deviation investigation and reporting
Key performance indicators generation and reporting
SOP / Technical report preparation and approval
Conduct/participate in audits / self-inspections
Periodic Product Reviews
Liaise with importation warehouse and import testing laboratories to
ensure sample delivery, receive testing data and work with laboratory
to resolve any issues related to testing of imported products.
Ensure records of batches certified are maintained, and dossiers and
samples archived in accordance with local SOPs and GMP requirements.
Effectively communicate with Supply Chain Hubs, Local Operating
Companies, manufacturing sites, External Supply managers and
importation warehouse and provide feedback to all on progress of
release as required
Present data on GSK?s behalf during regulatory inspections of
importation operations.
_EDUCATION_ and Experience Requirement
Basic Requirement
Third Level Degree in a Science related subject.
Experienced in manufacturing site operations, batch record review,
quality data review and operational quality requirements
Understanding of quality management principles and documentation
requirements for GMP compliance
Capable of working in multi-disciplinary teams across IT, Quality,
External Supply, Global Logistics, Supply Chain and Manufacturing
Working knowledge of GMP and GDP regulations
_ABLE TO_ present on aspects of the certification process where role
holder has responsibility during regulatory inspections
Experienced in application of GPS thinking and tools and knowledge of
performance measures
Closing date for applications on this role is Tuesday **Apply on the
website**th December **Apply on the website**.
Why work at GSK?
At GSK, our mission is to improve the quality of human life by
enabling people to do more, feel better and live longer. Our three
world-leading businesses research and deliver innovative medicines,
vaccines and consumer healthcare products. We need a talented and
motivated workforce to deliver against our strategy. To achieve this,
we strive to attract the best people and to create an environment that
empowers and inspires.
As a company driven by our values of Patient focus, Transparency,
Respect and Integrity, we know inclusion and diversity are essential
for us to be able to succeed. We want all our colleagues to thrive at
GSK bringing their unique experiences, ensuring they feel good and to
keep growing their careers. As a candidate for a role, we want you to
feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the
US, we also adhere to Affirmative Action principles. This ensures that
all qualified applicants will receive equal consideration for
employment without regard to race/ethnicity, colour, national origin,
religion, gender, pregnancy, marital status, sexual orientation,
gender identity/expression, age, disability, genetic information,
military service, covered/protected veteran status or any other
federal, state or local protected class*(
* US only).We believe in an agile working culture for all our roles.
If flexibility is important to you, we encourage you to explore with
our hiring team what the opportunities are.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or
employment agencies in respect of the vacancies posted . All
employment businesses/agencies are required to contact GSK&#**Apply on
the website**;s commercial and general procurement/human resources
department to obtain prior written authorization before referring any
candidates to GSK. The obtaining of prior written authorization is a
condition precedent to any agreement (verbal or written) between the
employment business/ agency and GSK.
In the absence of such written authorization being obtained any
actions undertaken by the employment business/agency shall be deemed
to have been performed without the consent or contractual agreement of
GSK. GSK shall therefore not be liable for any fees arising from such
actions or any fees arising from any referrals by employment
businesses/agencies in respect of the vacancies posted .Please
note that if you are a US Licensed Healthcare Professional or
Healthcare Professional as defined by the laws of the state issuing
your license, GSK may be required to capture and report expenses GSK
incurs, on your behalf, in the event you are afforded an interview for
employment. This capture of applicable transfers of value is necessary
to ensure GSK?s compliance to all federal and state US Transparency
requirements.
For more information, please visit GSK?s Transparency Reporting For
the Record site. We are currently hiring for Two Batch Release Specialist to be based
in our Dublin office.
These are Permanent positions.
Job Purpose
The Batch Release Specialist prepares product release dossiers for
presentation to the EU / UK QP Hub QPs. This involves reviewing batch
deviations, transit temperature control devices, sampling plan and
test results. It includes following up with the manufacturing sites
and Logistics groups on issues that arise from the reviews to support
batch certification processes.
The scope of this role includes support to GSK Trading Services, GSK
Export Ltd, Consumer Trading Services and ViiV Trading Services, and
may be expanded to support other entities if created. The EU / UK QP
Hub manages approximately **Apply on the website** batches per annum
and this role is key to ensuring compliant release of batches.
As Batch Release Specialist, you will be responsible for:
Liaise with Principal Trading Companies (PTC) and other groups for
co-ordination of batch release scheduling for products imported into
Europe
Prepare batch release dossiers for presentation to the QP in support
of compliant batch release and timely escalation of any issues
identified
Review associated records and documentation, including deviations and
liaise with the manufacturing site and QP to understand the impact of
the deviation on product quality prior to release ? manage
correspondence and communication between the parties to conclusion.
Raise and track iCargo deviations for transit temperature excursions,
liaising with the Pharma Logistics group and supplying sites to
resolve and close, ensuring escalation to the QPs.
Raise and investigate deviations relating to importation activities
Conduct activities to support EU / UK QP Hub processes related to
quality oversight for importation, including;
Quality meetings
Deviation investigation and reporting
Key performance indicators generation and reporting
SOP / Technical report preparation and approval
Conduct/participate in audits / self-inspections
Periodic Product Reviews
Liaise with importation warehouse and import testing laboratories to
ensure sample delivery, receive testing data and work with laboratory
to resolve any issues related to testing of imported products.
Ensure records of batches certified are maintained, and dossiers and
samples archived in accordance with local SOPs and GMP requirements.
Effectively communicate with Supply Chain Hubs, Local Operating
Companies, manufacturing sites, External Supply managers and
importation warehouse and provide feedback to all on progress of
release as required
Present data on GSK?s behalf during regulatory inspections of
importation operations.
_EDUCATION_ and Experience Requirement
Basic Requirement
Third Level Degree in a Science related subject.
Experienced in manufacturing site operations, batch record review,
quality data review and operational quality requirements
Understanding of quality management principles and documentation
requirements for GMP compliance
Capable of working in multi-disciplinary teams across IT, Quality,
External Supply, Global Logistics, Supply Chain and Manufacturing
Working knowledge of GMP and GDP regulations
_ABLE TO_ present on aspects of the certification process where role
holder has responsibility during regulatory inspections
Experienced in application of GPS thinking and tools and knowledge of
performance measures
Closing date for applications on this role is Tuesday **Apply on the
website**th December **Apply on the website**.
Why work at GSK?
At GSK, our mission is to improve the quality of human life by
enabling people to do more, feel better and live longer. Our three
world-leading businesses research and deliver innovative medicines,
vaccines and consumer healthcare products. We need a talented and
motivated workforce to deliver against our strategy. To achieve this,
we strive to attract the best people and to create an environment that
empowers and inspires.
As a company driven by our values of Patient focus, Transparency,
Respect and Integrity, we know inclusion and diversity are essential
for us to be able to succeed. We want all our colleagues to thrive at
GSK bringing their unique experiences, ensuring they feel good and to
keep growing their careers. As a candidate for a role, we want you to
feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the
US, we also adhere to Affirmative Action principles. This ensures that
all qualified applicants will receive equal consideration for
employment without regard to race/ethnicity, colour, national origin,
religion, gender, pregnancy, marital status, sexual orientation,
gender identity/expression, age, disability, genetic information,
military service, covered/protected veteran status or any other
federal, state or local protected class*(
* US only).We believe in an agile working culture for all our roles.
If flexibility is important to you, we encourage you to explore with
our hiring team what the opportunities are.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or
employment agencies in respect of the vacancies posted . All
employment businesses/agencies are required to contact GSK&#**Apply on
the website**;s commercial and general procurement/human resources
department to obtain prior written authorization before referring any
candidates to GSK. The obtaining of prior written authorization is a
condition precedent to any agreement (verbal or written) between the
employment business/ agency and GSK.
In the absence of such written authorization being obtained any
actions undertaken by the employment business/agency shall be deemed
to have been performed without the consent or contractual agreement of
GSK. GSK shall therefore not be liable for any fees arising from such
actions or any fees arising from any referrals by employment
businesses/agencies in respect of the vacancies posted .Please
note that if you are a US Licensed Healthcare Professional or
Healthcare Professional as defined by the laws of the state issuing
your license, GSK may be required to capture and report expenses GSK
incurs, on your behalf, in the event you are afforded an interview for
employment. This capture of applicable transfers of value is necessary
to ensure GSK?s compliance to all federal and state US Transparency
requirements.
For more information, please visit GSK?s Transparency Reporting For
the Record site.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
