Job Details: Deputy / Senior QA Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Deputy / Senior QA Specialist
Position: Deputy Responsible Person/ Senior QA Specialist - Temporary

Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company
focused on improving patients lives by identifying, developing and
commercializing meaningful products that address unmet medical needs.
We are continuing to expand our commercial product portfolio and our
research and development pipeline in therapeutic areas that can
leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology
areas in which we have a deep understanding of the patient journey and
a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If
youre looking to be a part of a company with an unwavering commitment
to improving patients lives and being a great place to work, we hope
youll explore our career openings and get to know Jazz
Pharmaceuticals.

Responsibilities:

This position is part of the Quality Systems team within Technical
Operations organisation based in Dublin. The role covers the
distribution aspects of the Irish Wholesale Distribution Authorisation
(WDA).

RESPONSIBILITIES:

* Ensure that the Jazz operations do not compromise the quality of
medicines by ensuring that systems are in place to monitor storage of
the product through the supply chain under the control of the Dublin
site WDA
* Ensure the conditions of the Wholesale Distribution Authorisation
are maintained
* Support the preparation, implementation and on-going maintenance
of the QMS systems and operational procedures, policies and other
related documentation, in compliance with applicable legislation,
regulations and regulatory guidance in context of GDP
* Review and approve applicable standard operating procedures
relating to GDP and advise upon the companys standard operating
procedures in relation to GDP
* Ensure that adequate records are maintained in relation to GDP and
ensure that they are accurate, legible and maintained in a secure
manner
* Have sufficient knowledge on the product distribution supply chain
and its complexity
* Participate in recall decision making and support product recalls
as required under the WDA
* Ensure any subcontracted activities which may impact on GDP are
approved and that suppliers and customers are approved

* Ensure the review, and where appropriate, preparation and regular
update of Quality Agreements and Service Agreements with licensees and
3rd party contractors

* Attend Management Reviews and Quality Council meetings to
participate in the review of the effectiveness of Quality and
Compliance Policy and Objectives in the context of the WDA
* Work with local Training Co-ordinators to ensure that applicable
personnel are trained in GDP and that continuous training programmes
are maintained
* Review documentation including change controls, deviations,
validation documentation, SOPs and specifications relating to
distribution activities
* Ensure that customer complaints relating to GDP are processed
efficiently and effectively
* Decide on the final disposition of returned, rejected, recalled or
falsified products
* Ensure returns to saleable stock are approved
* Ensure the potential for delays in distribution as a result of a
quality issue is escalated appropriately
* Ensure that self-inspections are performed at appropriate regular
intervals following a prearranged programme and necessary corrective
measures are put in place
* Keep up to date with any changes in the legislation and with
on-going training as identified

* Responsible for QA oversight of cold chain activities in markets
as per WDA, in accordance with local and global GDP requirements and
Jazz planning schedules
* Assess cold chain shipments and provide corresponding quality
decision on product.

* Be contactable by the HPRA the Competent Authority at all times
and provide the HPRA with the appropriate contact details
* Support the preparation of Health Authorities inspections and
provide support for regulatory submissions

* Keeping appropriate records of any delegated duties

QUALIFICATIONS/ PERSONAL COMPETENCIES:

* Bachelor&#**Apply on the website**;s degree in chemistry, biology
or a related discipline or extensive experience acting in the capacity
of Deputy RP or RP
* Minimum 3 years in international pharmaceutical and/or biotech
industry with increased level of responsibility and preferably a
minimum 2 years of experience in GDP
* Ability to operate efficiently in a complex matrix organization
and global environment
* Experience in managing contractors
* Sound awareness and understanding of pharmaceutical business,
especially with regard to quality, supply chain and regulatory
requirements.
* Experience interfacing with regulatory bodies or supporting
regulatory submissions is an advantage.
* Strong verbal and written communication skills and presentation
ability to various audience levels
* Lead auditor training and experience desirable

Jazz Pharmaceuticals is an Equal Opportunity Employer. Position: Deputy Responsible Person/ Senior QA Specialist - Temporary

Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company
focused on improving patients lives by identifying, developing and
commercializing meaningful products that address unmet medical needs.
We are continuing to expand our commercial product portfolio and our
research and development pipeline in therapeutic areas that can
leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology
areas in which we have a deep understanding of the patient journey and
a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If
youre looking to be a part of a company with an unwavering commitment
to improving patients lives and being a great place to work, we hope
youll explore our career openings and get to know Jazz
Pharmaceuticals.

Responsibilities:

This position is part of the Quality Systems team within Technical
Operations organisation based in Dublin. The role covers the
distribution aspects of the Irish Wholesale Distribution Authorisation
(WDA).

RESPONSIBILITIES:

* Ensure that the Jazz operations do not compromise the quality of
medicines by ensuring that systems are in place to monitor storage of
the product through the supply chain under the control of the Dublin
site WDA
* Ensure the conditions of the Wholesale Distribution Authorisation
are maintained
* Support the preparation, implementation and on-going maintenance
of the QMS systems and operational procedures, policies and other
related documentation, in compliance with applicable legislation,
regulations and regulatory guidance in context of GDP
* Review and approve applicable standard operating procedures
relating to GDP and advise upon the companys standard operating
procedures in relation to GDP
* Ensure that adequate records are maintained in relation to GDP and
ensure that they are accurate, legible and maintained in a secure
manner
* Have sufficient knowledge on the product distribution supply chain
and its complexity
* Participate in recall decision making and support product recalls
as required under the WDA
* Ensure any subcontracted activities which may impact on GDP are
approved and that suppliers and customers are approved

* Ensure the review, and where appropriate, preparation and regular
update of Quality Agreements and Service Agreements with licensees and
3rd party contractors

* Attend Management Reviews and Quality Council meetings to
participate in the review of the effectiveness of Quality and
Compliance Policy and Objectives in the context of the WDA
* Work with local Training Co-ordinators to ensure that applicable
personnel are trained in GDP and that continuous training programmes
are maintained
* Review documentation including change controls, deviations,
validation documentation, SOPs and specifications relating to
distribution activities
* Ensure that customer complaints relating to GDP are processed
efficiently and effectively
* Decide on the final disposition of returned, rejected, recalled or
falsified products
* Ensure returns to saleable stock are approved
* Ensure the potential for delays in distribution as a result of a
quality issue is escalated appropriately
* Ensure that self-inspections are performed at appropriate regular
intervals following a prearranged programme and necessary corrective
measures are put in place
* Keep up to date with any changes in the legislation and with
on-going training as identified

* Responsible for QA oversight of cold chain activities in markets
as per WDA, in accordance with local and global GDP requirements and
Jazz planning schedules
* Assess cold chain shipments and provide corresponding quality
decision on product.

* Be contactable by the HPRA the Competent Authority at all times
and provide the HPRA with the appropriate contact details
* Support the preparation of Health Authorities inspections and
provide support for regulatory submissions

* Keeping appropriate records of any delegated duties

QUALIFICATIONS/ PERSONAL COMPETENCIES:

* Bachelor&#**Apply on the website**;s degree in chemistry, biology
or a related discipline or extensive experience acting in the capacity
of Deputy RP or RP
* Minimum 3 years in international pharmaceutical and/or biotech
industry with increased level of responsibility and preferably a
minimum 2 years of experience in GDP
* Ability to operate efficiently in a complex matrix organization
and global environment
* Experience in managing contractors
* Sound awareness and understanding of pharmaceutical business,
especially with regard to quality, supply chain and regulatory
requirements.
* Experience interfacing with regulatory bodies or supporting
regulatory submissions is an advantage.
* Strong verbal and written communication skills and presentation
ability to various audience levels
* Lead auditor training and experience desirable

Jazz Pharmaceuticals is an Equal Opportunity Employer.

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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