In Norbrook we pride ourselves in being among the top companies in Northern Ireland and the top

veterinary pharmaceutical companies globally. We develop & manufacture veterinary medicines,

supplying products to 120 countries globally. With a strong portfolio of existing products and

significant investment in R&D to launch new products annually, we have opportunities for individuals

to join us and develop their career in a global company.

Our business strategy is supported by our Values - Customer Value, One Team, Results Driven,

Excellence, Innovation, and Quality - and we support our employees to live the behaviours that

creates our culture. Our on-going success is based on the expertise, knowledge and innovation of our

employees. If you are interested in joining our team here at Norbrook and supporting our vision, then

**Job Overview**

Working within the R&D Department and reporting to the GLP QA Manager, the QA inspector will be

responsible for conducting inspections within the GLP Division of R&D to ensure compliance with GLP

in the upkeep of the GLP Quality Management system.

**Main Activities/Tasks**

The main duties of this role will include but will not be limited to the following:

Perform live phase and data inspections of the various GLP sections (laboratories, animal facility,
test article facility, data analysis, study management, archive facility) for compliance with GLP
Guidelines.

Generate deficiency reports, notify relevant parties including QA and Test Facility Management of
inspection findings and recommended actions.

Assist in the upkeep of the GLP Change control, Deviations, CAPA and Laboratory investigations
databases to contribute to the continued development, performance and compliance of the GLP
section and quality of new product development and life cycle management.

Contribute effectively to the regular, documented Quality review process, that includes a review
of Quality performance versus key Quality metrics/KPIs, for all key elements of the PQS including:
- Service Level Agreements with the CROs as applicable
- Document Control, Retention & IT Systems
- Review and trending of Deviations and Laboratory investigations
- Review and tracking of CAPAs
- Clinical Facilities and Study Audit Program
- Change Management

Conduct of facility audits of the GLP facilities.

Ensure critical phases, data and reports are audited and findings reported as per in house SOPs.

Assist in the control/reconciliation of controlled study and facility documents.

Maintain an awareness of current national and international regulations and requirements for GLP
and GCP and other relevant quality standards and advise on the same.

**Essential Criteria: **

Educated to degree level in a relevant life science related discipline **OR** a minimum of two years’
experience working in a GLP or GMP environment (full training will be provided)

Experience in maintenance and trending of deviation and laboratory investigation systems

Experience in managing Change Control

Demonstrate the ability to read and interpret laboratory procedures, methods and data, GLP and
regulatory guidance

Strong attention to detail

Excellent organisation and communication skills (written and verbal) across a range of
interdepartmental levels

Demonstrate the ability to work independently on assigned responsibilities as well as part of a
team to a high standard to meet deadlines.

A full driving licence is required

**Desirable Criteria: **

Experience working in a QA function in a GLP or GMP environment

Experience in the approval, introduction and control of study and facility related documentation

Experience developing and maintenance of Excel spreadsheets for tracking purposes

Understanding of bio-analysis

Demonstrable experience in a Clinical setting (in-house and/or CROs etc.) working on clinical &
non clinical studies operating to GLP

Understanding of Good Laboratory Practice principles and standards, and quality management
systems

Knowledge of FDA/EMA practices and guidelines

Experience in the trending and interpretation of analytical data

Experience of preparing responses to regulatory queries

**Duration**:Permanent, full time.***

**Location**: Newry, Co. Down

**Remuneration**: Salary Attractive

**Benefits**: Free Life Assurance, Company Pension Scheme, 30 days annual leave, Wedding Leave,
Employee well-being initiatives, Healthcare plan, Company Sick Pay, Employee Assistance
Programme, On-site free parking, Canteen Facilities, Employee Perks scheme, Discounted Car
Insurance, Annual Employee raffle, employee recognition scheme, career development
opportunities and much more

**Contact**:The Human Resources Department

**_Norbrook Laboratories Limited employs a workforce with members of all sections of the _**
**_community and is committed to appointing people purely on the basis of merit. In accordance with _**
**_our equal opportunities policy we would particularly like to welcome applicants from