Senior QC Systems Technical Specialist

CK Group are recruiting for a Senior QC Systems Technical Specialist, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a fixed term contract basis for 12 months.

Role:

This job is responsible for providing technical support for all laboratory electronic systems (e.g. LIMS, CDS) used within the Quality Control Laboratory. This includes master data maintenance, providing technical support to understand and resolve issues and implement agreed solutions and supporting future enhancements (e.g. the deployment of new modules, software updates).

Key duties will include:

• Create and maintain QC electronic system master data.
• Provide technical support for the operation, maintenance and improvements of QC electronic systems to support the business needs.
• Support the deployment of new/upgraded QC electronic systems internally.
• Support the procurement, validation and qualification of new QC electronic systems.
• Generate and review qualification and validation documentation in line with EML procedures.
• Coordinate with EIT Team ensuring all QC electronic systems are maintained in line with IT policies.
• Provide support to QC Analysts to ensure software changes are managed in line with data integrity and EML procedure requirements.
• Prepare and update SOPs and training materials for use and administration activities for QC electronic systems.
• Raise and support the change control process to ensure changes are managed in line with procedures and the requirements for qualification and validation are included.
• Provide technical information in response to global regulatory equipment/method queries as required.

Your Background:

• Degree or equivalent experience in a science discipline.
• Strong working knowledge of pharmaceutical Quality Control electronic systems, including their qualification and validation.
• Significant previous experience (at least two years) in creating/updating master data for a laboratory LIMS and/or CDS system, within the pharmaceutical industry.
• Experienced as an end user of QC electronic systems.
• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers.
• Ability to understand and analyse user requirements to facilitate changes and system improvements.
• Ability to interpret complex data and present key findings.
• Ability to describe technical information in easy-to-understand terms.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence.