Job Details: QA Specialist / QP


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
QA Specialist / QP
Team Horizon currently has an exciting opening for a QA Specialist/QP
to work on our client&#**Apply on the website**;s manufacturing
facility in Cork. In this role, you contribute to the implementation
and maintenance of Quality Assurance actions in compliance with the
current GMP regulations.

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:

* Implementation, maintenance, and development of QA systems

* Reviewing the GMP documentation egg, SOPs, reports, methods,
specifications, validation protocols, quality contracts etc., and
Exceptional Documents e.g. NCRs/PNCRs, Planned Deviations etc.

* Writing and reviewing QA department procedures and reports e.g.
protocols, SOPs, environmental reports etc. Reviewing and Approving
other departmental procedures and reports

* Internal Auditing (when required) of FLI Departments and external
auditing (when required) of Material and Service Suppliers (including
Supplier Management)

* Alerting the QA Compliance Manager in case of detection of a
discrepancy / noncompliance

* Participation in change control activities on site

* Assist in the preparation and reviewing of QA department reports and
metrics e.g. monthly quality report, discrepancy reports, exceptions
reports, KPI reports

* Reporting and communication to QA Compliance Manager on key events
and issues etc. via normal in-house reporting structure e.g. meetings,
formal reports etc.

* Participation in initiatives and action plans for the development of
QA and improvement of GMP compliance

* Follow-up of audits and/or inspections carried out at the site by
the authorities or clients

* Assist in preparation and presentation of GMP training programs

* Represent QA on BeX projects to ensure compliance to GMP

* Ensure QA activities are executed in line with in-house procedures
and in compliance with requirements of cGMP

* Be the SAP Local Key User for the QA Department

* Be the Site Lead for Isotrain System

* Environmental Monitoring - review of data, monthly report, NCRs,
Annual Report

* Assist in New Product Introduction Activities when required

* Contribute to the quality assessment of clinical, pre-commercial
product, and IMPs

* Contribute to the quality assessment of commercial finished product

What you need to apply:

* Relevant 3rd level degree in science or quality

* Experience to requirements for position of Qualified Person as
defined in EU GMP volume 4 and annex **Apply on the website**

* Previous management/supervisory experience advantageous

* Experience of GMP auditing and documentation

* Good organisation skills and time management

* Ability to critically assess issues and execute problem solving Team Horizon currently has an exciting opening for a QA Specialist/QP
to work on our client&#**Apply on the website**;s manufacturing
facility in Cork. In this role, you contribute to the implementation
and maintenance of Quality Assurance actions in compliance with the
current GMP regulations.

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:

* Implementation, maintenance, and development of QA systems

* Reviewing the GMP documentation egg, SOPs, reports, methods,
specifications, validation protocols, quality contracts etc., and
Exceptional Documents e.g. NCRs/PNCRs, Planned Deviations etc.

* Writing and reviewing QA department procedures and reports e.g.
protocols, SOPs, environmental reports etc. Reviewing and Approving
other departmental procedures and reports

* Internal Auditing (when required) of FLI Departments and external
auditing (when required) of Material and Service Suppliers (including
Supplier Management)

* Alerting the QA Compliance Manager in case of detection of a
discrepancy / noncompliance

* Participation in change control activities on site

* Assist in the preparation and reviewing of QA department reports and
metrics e.g. monthly quality report, discrepancy reports, exceptions
reports, KPI reports

* Reporting and communication to QA Compliance Manager on key events
and issues etc. via normal in-house reporting structure e.g. meetings,
formal reports etc.

* Participation in initiatives and action plans for the development of
QA and improvement of GMP compliance

* Follow-up of audits and/or inspections carried out at the site by
the authorities or clients

* Assist in preparation and presentation of GMP training programs

* Represent QA on BeX projects to ensure compliance to GMP

* Ensure QA activities are executed in line with in-house procedures
and in compliance with requirements of cGMP

* Be the SAP Local Key User for the QA Department

* Be the Site Lead for Isotrain System

* Environmental Monitoring - review of data, monthly report, NCRs,
Annual Report

* Assist in New Product Introduction Activities when required

* Contribute to the quality assessment of clinical, pre-commercial
product, and IMPs

* Contribute to the quality assessment of commercial finished product

What you need to apply:

* Relevant 3rd level degree in science or quality

* Experience to requirements for position of Qualified Person as
defined in EU GMP volume 4 and annex **Apply on the website**

* Previous management/supervisory experience advantageous

* Experience of GMP auditing and documentation

* Good organisation skills and time management

* Ability to critically assess issues and execute problem solving

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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