CK Group are recruiting for a Senior QC SystemsTechnical Specialist, to join a well-established and successfulglobal pharmaceutical company, based in Hatfield, Hertfordshire, ona fixed term contract basis for 12 months.
Role:
This job is responsible for providing technical support for alllaboratory electronic systems (e.g. LIMS, CDS) used within theQuality Control Laboratory. This includes master data maintenance,providing technical support to understand and resolve issues andimplement agreed solutions and supporting future enhancements (e.g.the deployment of new modules, softwareupdates).
Key dutieswill include:
* Createand maintain QC electronic system masterdata.
* Provide technical support for theoperation, maintenance and improvements of QC electronic systems tosupport the business needs.
* Support thedeployment of new/upgraded QC electronic systemsinternally.
* Support the procurement, validationand qualification of new QC electronicsystems.
* Generate and review qualification andvalidation documentation in line with EMLprocedures.
* Coordinate with EIT Team ensuringall QC electronic systems are maintained in line with ITpolicies.
* Provide support to QC Analysts toensure software changes are managed in line with data integrity andEML procedure requirements.
* Prepare and updateSOPs and training materials for use and administration activitiesfor QC electronic systems.
* Raise and supportthe change control process to ensure changes are managed in linewith procedures and the requirements for qualification andvalidation are included.
* Provide technicalinformation in response to global regulatory equipment/methodqueries as required.
YourBackground:
* Degree orequivalent experience in a sciencediscipline.
* Strong working knowledge ofpharmaceutical Quality Control electronic systems, including theirqualification and validation.
* Significantprevious experience (at least two years) in creating/updatingmaster data for a laboratory LIMS and/or CDS system, within thepharmaceutical industry.
* Experienced as an enduser of QC electronic systems.
* Ability toestablish and maintain effective working relationships andcommunication links within EML, affiliated organisations and othercustomers.
* Ability to understand and analyseuser requirements to facilitate changes and systemimprovements.
* Ability to interpret complex dataand present key findings.
* Ability to describetechnical information in easy-to-understandterms.
Apply:
It isessential that applicants hold entitlement to work in the UK.Please quote job reference 107 825 in allcorrespondence.