Mundipharma Research Ltd
Job Description
JOB TITLE:
Laboratory Informatics
Support Scientist
SECTION:
DEPARTMENT:
Technical Support
COMPANY: Mundipharma Research Ltd
RESPONSIBLE TO:
Section Manager
Technical Support
DATE:
A.
Laboratory Informatics
August 2012
BROAD PURPOSE OF JOB
To provide support for the development, qualification, validation and maintenance of electronic
systems including the Laboratory Information Management System (LIMS), Chromatography Data
System (CDS), electronic Process Management and Compliance system and Training Database
system.
To provide support for the processing, collection and storage of data from laboratory instruments
using specific equipment applications.
B.
SPECIFIC DUTIES & RESPONSIBILITIES
1.
Undertake a practical and supporting role within the European Technical Development Directorate
(ETD), with the aim of making the greatest contribution to supporting electronic systems for the
Paperless Laboratory suit of applications and other divisional applications including equipment
specific software where appropriate.
2.
Carry out routine maintenance for applications, including logging and monitoring of change control
requests, creation of user accounts, assignment of application permissions, creation and
modification of electronic tests and specifications, development of electronic methods and creation
and archiving of projects. Ensure a full audit of all changes is maintained.
3.
Review, maintain and update technical documentation such as; Standard Operating Procedures
(SOPs), training plans and validation test scripts. Assist with writing documentation as required for
technical equipment implementation, upgrades, system fixes and patches.
4.
Assist with running test protocols for equipment validation, data migration, patch management and
process verifications. Help plan and co-ordinate business continuity for the divisional applications
and ensure contingency procedures are viable during the event of application failure. Run reports
to ensure system back-up procedures are adequately performed. Where appropriate work closely
with the Quality and IT Departments to ensure the appropriate qualification of the work is carried
out and the validation status of the equipment is maintained.
5.
Provide assistance in the planning and co-ordination of electronic systems requirements for ETD
and other departments where appropriate. Provide training to staff to maintain and develop the
effectiveness of ETD and help trouble shoot problem areas for the users as necessary.
6.
Assist with carrying out training for other team members, in order to maintain and develop the
effectiveness of the Department, ensuring individual training records are completed and kept up to
date.
7.
Take responsibility for personal training and development in order to reach and maintain the
required level of skills, knowledge and experience to perform the role. Maintain accurate training
records. Proactively participate in the company Performance Assessment System, including the
agreement of objectives which meet the business requirements and enable personal development
and progression.
8.
Ensure all work is undertaken in compliance with the requirements of cGxP (Current Good
‘Clinical, Laboratory, Manufacturing, Pharmaceutical’ Practice), relevant codes of practice (e.g.
Medicines Act 1968, EU Directives) and company/departmental SOPs. Ensure compliance with
the requirements of Control of Substances Hazardous to Health (COSHH) and Health and Safety
at Work Act 1974 (HASAWA).
9.
Undertake any other reasonable tasks to help fulfil the objectives of the Department.