Medical/Pharmaceutical/Scientific

QC Laboratory Systems Specialist

Full Time Permanent

Anonymous

Truly global Pharmaceutical Company seeks an experienced 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.

About the role:

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.

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.
Establishes and maintains an appropriate stock / supply of calibration standards (e.g. certified weights, UV filter sets, etc…) and maintains their validity to support the ongoing self-assessment / calibration activities within the QC Laboratory.
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.
Provides functional support to the Team Leaders and Senior Analysts within the QC Department as and when resource limitations demand.
Raising and oversight of instrument / equipment-based deviations and their subsequent investigation.
Assists in laboratory investigations (LIRs) and deviation investigations where required.
Carries out other reasonable duties as and when required by the Head of QC.
Represents the company at Customer, Internal, and Regulatory audits, interfacing directly with the auditors / inspectors where required.
Determine instrument / equipment suitability through reliability review and investigation of industry best practice to identify potential purchases
Authorised to interact directly with existing / potential vendors to obtain specifications, quotes, site visits / surveys to support instrument / equipment changes and improvements
Determines level of and type of qualification required to support new and existing laboratory instruments / equipment and their supporting services and systems
Authority to review and approve external vendor maintenance, qualification and calibration reports for quality, authenticity and acceptance in accordance with GMP

Skills & 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 Location: Kent, England