Laboratory Documentations Reviewer

4 weeks ago

Newry, United Kingdom Norbrook Laboratories Full time

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

**Laboratory Documentations Reviewer**

**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 Tasks/Activities**:

- 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,
- Preparation of data packages for submission to regulatory authorities.
- 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.
- 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**:
form in order to be considered:

- 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**:
Due to the nature of the role preference will be given to applicants demonstrating the

following 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

**Additional Information**:

- Applicants should be able to provide proof that they have a right to work in the UK at the

considered.

**Benefits**:

- Free Life Assurance - Employee Assistance Programme
- Company Pension Scheme - On-site free parking
- Healthcare cash plan - Canteen Facilities
- 32 days annual leave - Employee Perks scheme
- Wedding Leave - Employee Recognition scheme
- Company Sick Pay - Career development opportunities
- Employee well-being initiatives

**_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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