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