Job Description
Post:
Programme Officer (QA & GLP Implementer)
Responsible to:
Carl Henry (Head of Research Governance)/Helen Williams (LITE)
Group:
Research Governance and Contracts Office
Summary of role:
The Department of Vector Biology at LSTM is one of the largest of its kind with a broad portfolio of
research and technical assistance activities targeted at improving the control of insect borne
diseases. A dedicated team within the department, the Liverpool Insect Testing Establishment (LITE)
provides a facility for testing lead chemicals for use in the control of public health pests. Our activities
are currently performed according to good quality standards and it is our intention to formally apply
for GLP accreditation to MHRA Standards over the next 12-18 months. This position will provide
compliance support for LITE in readiness of GLP accreditation. The role also involves project
management and training of staff responsibilities and supervision to ensure a smooth transition
to a GLP accredited facility. We are looking for an individual with strong GLP experience with a
Quality Assurance background ideally within an industrial environment. The position is based at
the LSTM.
Main duties:
Research and research management

To develop and implementation/design of quality management systems within LSTM
Development. Introducing new ways of working and new QA processes/systems to LSTM.

Establish a formal quality framework.

Ownership of the above system, reviewing as required to relevant industry standards and
implementation of new ways of working, driving to impact.

Define internal audit process within LITE to comply with cGLP, co-ordination and carrying out
audits, as defined by this schedule.

To write and review Standard Operating Procedures (SOPs) using an appropriate/defined
Document Management System

Provide Quality Assurance and validation advice when setting up specifications/quality system
documents.

Employing risk assessments tools during decision making steps and be able to justify in writing
these decisions.

Implement and operate a programme of supplier audit in liaison with LSTM purchasing team
and approval for raw materials for use in LITE.

To conduct and liaise with GLP/QA partners via IVCC and Industry networks to establish
quality improvement cycles

Provide review, QA authorisation signature and audit all LITE generated client record sheets
ensuring all documentation meets GLP (Good Laboratory Practice Standards).Establish and
maintain a fully validated and compliant system to ensure:
 Document life-cycle management
 Physical and electronic archiving systems
 Planned document review process
 Robust change control system
 A system to support curation of archived documentation
 Testing deviation investigations and resulting CAPAs (Corrective Action,
Preventative Actions) and complaint investigations are backed up by rigorous
process

To report on quality progress
Summarize quality progress for Research Governance and LITE on a quarterly basis or
more frequently as/when requested.

To be the ‘point-person’ for in-depth support and liaison with LITE partners (on matters of
quality assurance).
Capacity Development



To train trainers in LITE approaches
To present quality methods and outputs to relevant as requested
Introducing best practice and standardisation with a questioning mind-set
Strategic development

To assist with strategic planning for LITE with the aim of enhanced knowledge uptake into
policy and practice.
Line management



Matrix team management of varies groups within LSTM including close working with
procurement manager to establish a fit for purpose supplier system.
Effective working across two work areas with LSTM -LITE and Research Governance
Making independent decisions with limited supervision.
Person Specification: Quality Assurance and Compliance Co-ordinator (LITE)
Criteria
Education &
Training
Experience
Competencies

BSc(hons) in science based subject

Relevant experience of working within a research
laboratory in a GLP testing environment

Experience of working to health and safety
regulations and legal requirements , and writing
of relevant risk assessments




Skills, Abilities
and
Knowledge















Interests

Documentation controller/management
experience and experience in quality assurance
role in industrial/compliance based setting.
Previous Quality Assurance role demonstrating
ability to professionally challenge
Proven quality experience
Demonstrable experience in delivering timely
research outputs against key indicators
MHRA experience
FDA experience
Experience with qualification and validation of
plant equipment and processes, including writing
and execution of protocols.
Knowledge of health and safety regulations and
legal requirements and ability to carry our risk
assessments
Challenging and investigating nature
Excellent verbal & written communication skills,
with the ability to communicate at all levels
Numerate, with good working knowledge of
Microsoft Office packages
o EDCL certification
Flexible attitude to work, and excellent time
management skills
Knowledge and ability to carry out Internal
auditing to aid compliance
Ability to define auditing strategy
Ability to define new quality systems in
compliance with regulatory requirements
Ability to contribute to up-skilling of current staff
in new quality processes
Ability to write reports for a variety of audiences
Excellent presentation skills to policy makers in
different contexts
Ability to drive progress
An enthusiasm for contributing to a multidisciplinary program and working towards the
goal of improving vector control
Essential
Desirable
E
E
Assessment
Application Form/CV
Application form/CV,
Assessment &
interview
E
E
E
E
E
E
D
Application form/CV,
& interview
E
E
E
E
E
D
E
E
E
E
E
E
E
E
E
Application form/CV
& interview