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Documentation Reviewer

4 weeks ago

Newry, United Kingdom Norbrook Laboratories Full time

External Advert

Documentations Reviewer

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 Norbrook and supporting our vision,

**Job Overview**

Based within the R&D GLP Clinical Section the Laboratory Data Reviewer will be responsible for
reviewing laboratory data to ensure accuracy and validity of analysis conducted within the
department. This role involves the review of data generated within the Chromatography Data Capture
System (Empower ) and associated analytical records and generation of analytical and validation
reports to ensure delivery of Studies and validations to project timelines.

**Main Activities/Tasks
- Review of GLP Laboratory study & validation analytical data (electronic and paper data) for

accuracy and validity in line with GLP (SI 3106), VICH guidance and in-house procedures.
- Communication with the laboratory analytical and Method Development & Validation team

to ensure data queries are addressed prior to data set approval.
- Preparation/review of Study Analytical Reports as per VICH guidance and in line with project

timelines,
- Review and assist with the implementation of Standard Operating Methods (SOMs) and

Standard Operating Procedures (SOPs) as applicable for the GLP Laboratories.
- Review of routine equipment records to ensure all equipment remains in a validated state.
- Routine review of laboratories and associated routine records to ensure audit readiness.
- Conduct of Audit Readiness inspections.
- Assist in the review of Validation Protocols in line with regulatory requirements.
- A key player in a cross-functional team working closely with analysts, laboratory management,

GLP Study Directors and QA to ensure analytical data and reports are reviewed and delivered
in compliance with GLP and VICH requirements.

**Essential Criteria:
- A degree in a relevant Science based discipline or a minimum of 2 years practical HPLC

analytical experience.
- Knowledge of Electronic Chromatography Data Capture system (Empower or similar

chromatography software package).
- Good team player, organised and accurate with strong documentation skills.
- Ability to develop effective working relationships in cross-functional teams and work closely

with a range of departments.
- Self-directed, can work independently, and proactive as a team member, being highly

motivated and result orientated.
- Good written and oral communication skills, able to interact positively and professionally with

a range of departments

**Desirable Criteria:
- Experience of preparing laboratory method, Standard Operating Procedures (SOPs) and

laboratory analytical reports
- Experience working with an electronic chromatography data capture system
- Experience reviewing data within an electronic chromatography data capture system
- Previous Data records review experience within a GMP/GLP laboratory environment
- Knowledge of method validation according to GMP/GLP guidelines would be an advantage

**Duration**:Full Time, Permanent***

**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 the Protestant
Community.

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