QA Glp Inspector

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

one of 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

**QA GLP Inspector**

**Job Overview**

The QA GLP Inspector is responsible for conducting inspections and generating audit

reports within the R&D GLP Division to ensure compliance with Good Laboratory Practice

Guidelines (SI 3106) and OECD GLP standards published as OECD Principles on Good

Laboratory Practice (Revised 1997, ENV/MC/CHEM (98)17) and the requirements of

Directive 2004/9/EC and 2004/10/EC and associated national legislation. Assist in the

upkeep of a current and effective Quality Management System in accordance with

Regulatory Authority requirements, company standards and best practices.

**Main Activities/Tasks**

The main tasks are outlined within the following areas, wherein it is expected that the QA

Officer will be pro-active rather than reactive:

- 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 International 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:
o Service Level Agreements with CROs as applicable
- Document Control, Retention and 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 related systems and advise on
same
- Auditing of the Pharmacovigilance (PV) facility, external PV distributors, external PV

service providers and PV satellite offices
**Essential Criteria**:
form in order to be considered:

- Educated to degree level in a relevant life science related discipline or a minimum of two

years’ relevant experience working within a GLP or GMP environment. (Full training will
be provided).
- Previous laboratory experience, including reviewing data using Empower (CDS).
- 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**:
Due to the nature of the role preference will be given to applicants demonstrating the

following 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 and 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
- Knowledge of Pharmacovigilance (PV) guidelines and previous experience of conducting

PV audits.
- Experience in the trending and interpretation