The role of the Instrument Specialist is to ensure the day to day running of all laboratory instruments, minimizing any downtime in the laboratory due to instrumentation issues and ensuring all equipment is installed and maintained in a validated state. The role covers Drug Substance and Drug Product instrumentation in clinical and commercial areas for ADC. The Instrumentation Specialist also has responsibilities for management of selected Analytical Instrumentation in the ADC department.
The Instrumentation Specialist has overall responsibility for maintaining Laboratory Instrumentation in ADC/PDC. The Instrumentation Specialist will lead troubleshooting activities and use external support as required to meet customer targets.
· The Instrumentation Specialist is responsible for ensuring all Instrumentation activities comply with cGMP, including acting as auditee for this area. The Instrumentation Specialist assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as trade compliance, human resources and spending are also responsibilities of the role for this scope of work.
· Installs all instrumentation in accordance with laboratory validation policies, procedures and guidelines. Reviews and approves validation activities for instrumentation.
· Provides a preventative maintenance service to ensure functionality and a calibration service to maintain the instruments according to their working specifications. Leads shut-down PM/PV as required and ensures all contract/support personnel on site comply with site safety and GMP requirements.
· Ensures that all instruments are maintained in a validated state through a PM/PV schedule and ensuring that this schedule is adhered to by the Instrument group and contract vendors.
· Responsible for troubleshooting issues with all instrumentation, ensuring that incident reports are raised, investigated and closed out as required and for coordinating with vendor service engineers to come on site.
· Ordering and installing new laboratory equipment, ensuring associated documentation is in accordance with company's SDLC (System Development Life Cycle).
· Assumes the role of auditee where required for instrumentation and ensures timely closure of any audit observations.
· Supports the vendor contract development and renewal business process.
· The incumbent operates as part of self-directed team in carrying out day to day function and assigning priorities.
· On assignment, the incumbent participates in departmental initiatives on improved compliance and quality systems.
· BSc. (or equivalent experience base) in analytical chemistry, pharmaceutical science or a related discipline.
· Knowledge of Quality Systems, Laboratory testing documentation, Validation Principles and Guidelines.
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