| Quality Systems Manager - Permanent |
Job ID 176495 |
| Location: Scotland | Status: Applicants Required |
| Date Updated: 22 December 2008 |
| | Further information call: 01489 898274 |
Important: Detailed knowledge of Systems Development Life Cycle Methodology.
Introduction:
We are currently looking for a Senior Systems Manager to join a leading CRO company based in Scotland.
Job Specification:
Job Purpose:
Provides management oversight to UK based Quality System's team along with comprehensive and advanced technical expertise to implement and maintain Quality systems to meet internal and external client needs. Analyse business processes and interacts with end users to assist in the development of detailed requirements, test protocols and operating procedures. Provides support for existing site-specific applications and facilitates implementation of new applications.
JOB ACCOUNTABILITIES and JOB CONTENT
To manage the Quality System’s resource at two of the facilities.
Oversee active projects within the Quality Systems group. This may include coordination with other project leaders within or projects outside the group.
Manage external contractors, developers or specialist resources from the business units e.g. DBA support or Operations staff assisting with OQ/PQ execution etc.
To develop and maintain project plans.
To provide Senior Management with up-to-date project status information as and when required.
To provide second line support for current business systems (either bespoke or OTS) used within the business.
To assist business lines to develop user requirements for quality systems.
To develop functional specifications, technical specifications and other CSV related documentation.
To develop bespoke applications using the companies global CSV strategy making use of the above fore mentioned technologies.
To assist in the overall CSV activities for any given project.
To provide technical guidance and to assist in the development of any system plans relating to the business.
Manage the support, maintenance and administration of quality regulated systems.
Provide relevant system use and administration training to staff
Develop and maintain communication channels between business lines and the different sites with regard to systems, quality, developments and support.
Requirements:
Detailed knowledge of Systems Development Life Cycle Methodology.
Detailed knowledge of Computer Systems Validation practices.
Detailed knowledge of regulations relevant to computer systems, specifically including 21 CFR, Part 11.
Technical writing skills.
Experience in programming and relational database design highly desired.
Competencies: Self-manage, time manage, communication, good written and oral skills, ability to work to deadlines is a must.
To apply for this position, candidates must be eligible to live and work in the UK