Job Number: 17575

External Description:

Job Title: QC System Specialist
Location: Yorkshire/Humber   
Contract: Permanent, Full Time 
Work Hours: 37.5 

 

Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services are currently recruiting for a QC System Specialist on behalf of a global CDMO organization. 

 

Role Purpose:

In this role you will be responsible for the management and support of Quality Control systems throughout their lifecycle: 

• System/device specification
• Commissioning/Qualification/Validation
• Maintenance
• Decommissioning

You will collaborate with system owners and key members of the Quality, Operations and IT/OT teams in order to implement best-practice and integration with the site/global Infrastructure.

 

Key Accountabilities: 

Front End

• Support implementation of OT hardware and infrastructure within QC environment
• Provide consultation with regards to software/systems implementation and validation.
• Define specifications and qualification requirements
• Execute/oversee qualification activities including user acceptance
• Work with vendors for initial qualification and facility requirements
• Identify current and emerging technologies which could benefit QC/add value and promote these opportunities internally.

 

Business Partnering and Solution Provision

• Perform technical support and systems administration for QC systems.
• Provide consultation with regards to software/systems implementation and validation.
• Manage service contracts and routine maintenance activities for QC equipment/systems
• Manage spare parts and system up-time
• Provide hands-on system administration support (configuration, access management, system audit trails) for installed solutions
• Author GxP business and technical requirements for system management and control
• Train QC equipment users and Instrument Responsible people on systems
• Perform system periodic reviews
• Act as System Data Owner, ensuring integrity of data throughout the lifecycle and compliance with ALCOA+ principles
• Manage systems and data throughout the lifecycle, including risk management principles

 

Key Requirements: 

• Technical experience within GMP QC laboratory environment, including project management, equipment/system qualification/validation.
• Experience as Specialist / Super User / SME  in a knowledge management software, electronic laboratory notebooks or laboratory information systems
• Ideally familiar with systems such as HPLC, ICP-OES, IC, XRPD.
• Focus on high quality; good at planning, organizing and communication.
• Empowerment, motivating others and development direction
• Understand operational technologies and data flows
• Experience developing system maintenance/resource/testing plans and costings
• Ability to work with Data: Analysis, trending and interpretation
• Ability to collaborate with broad cross functional teams
• Good Knowledge of Computer Systems Validation
• Knowledge of system implementation, documentation and maintenance.
• Ability to manage and execute multiple IT/OT tasks
• Experience of workstation, Server and Infrastructure administration and support

Job Number: CONF 5498

Community / Marketing Title: QC Systems Specialist

Location_formattedLocationLong: Hull, Yorkshire and the Humber GB