QC Laboratory Equipment Specialist
- Experience Level
- Experienced (non-manager)
Truly global Pharmaceutical Company seeks an experienced QC Laboratory Equipment Specialist.
About the role
The QC (Quality Control) Laboratory Systems Specialist is responsible for the oversight of the qualification status and maintenance of the laboratory's instrumentation and operational equipment and reports to the Head of QC.
The role has responsibility for the establishment and maintenance of suitable systems to allow the visibility and tracking of instrument availability, its qualification / calibration status, the scheduling of planned maintenance activities, and rapid resolution of breakdowns to ensure the Quality Control department is properly supported and able to execute testing requirements.
Duties may include:
- Establishes implements and maintains suitable systems for the tracking of instrument / equipment qualification / calibration status to provide status and performance metrics to QC Management. Maintains reporting KPIs for equipment availability and issue resolution, develops other suitable KPIs and tracking systems to aid compliance and continuous improvement.
- Liaises with service providers / vendors and Procurement to set-up, update, or terminate service contracts to support instrument / equipment reliability.
- Liaises with Engineering and service providers to schedule planned maintenance activities in accordance with SAP and maintain appropriate records.
- Liaises with QC Analytical Management and Team Leaders to schedule in planned maintenance work to minimise down-time and impact on product testing.
- Generates and issues 'Permits to Work' and conducts basic safety reviews prior to servicing / maintenance activity on site.
- Ensures that all data generated from maintenance, validation, and repair activities are reviewed and in line with the principles of ALCOA.
- Conducts regular reviews of maintenance activities, procedures, and records and acts to bring them up to date to ensure they meet 'current best practice' and identify continuous improvement opportunities. Conduct regular reviews of laboratory instrumentation and equipment age and reliability.
- Works with the Head of QC, QC Analytical Management and QC Team Leaders to identify instruments / equipment at risk of failure, obsolescence, or single point of failure and establishes a retirement and replacement plan to remediate the risk whilst controlling spending.
- Leads QC instrument / equipment projects; raises relevant change control and validation documentation to support new instrument / equipment introduction, changes to, or retirement and removal.
- Ensure that the core current Good Manufacturing Practice (cGMP), Good Control Laboratory Practice (GCLP), and Data Integrity are maintained by design through the Change Control and Validation processes.
- Raising and oversight of instrument / equipment-based deviations and their subsequent investigation.
- Assists in laboratory investigations (LIRs) and deviation investigations where required.
- Represents the company at Customer, Internal, and Regulatory audits, interfacing directly with the auditors / inspectors where required.
Skills and experience:
- A graduate with a Chemistry or Engineering degree, or equivalent
- At least 5 years' experience in a laboratory environment or within a validation function
- At least 5 years' experience working within the Pharmaceutical or Medical Device industry.
- Detailed knowledge of analytical techniques both theoretical and practical.
- Experience in working on the bench both in manual and instrument environments.
- Experience in instrument / equipment qualification, validation, and change management.
- Experience in project planning and delivery.
- Experience in influencing people's behaviour in a positive manner.
- Knowledge of relevant GMP regulations and policies.