QC Specialist

Job Description

Truly global Pharmaceutical Company seeks an experienced QC IT and Equipment Specialist.About the roleThe Quality Control IT & Equipment Specialist is responsible for the oversight of the qualification status and maintenance of the laboratorys instrumentation and operational equipment and reports to the QA & Compliance Manager.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 resolutionof breakdowns to ensure the Quality Control department is properly supported and able to execute testing requirements.Management, coordination and support of activities relating to the maintenance, development, troubleshooting, auditing and validation of GMP-relevant IT application systems and IT infrastructure components, such as Trackwise, Empower, Tiamo 2.5, WinLab UV,TruScan 2.6.0, TOC DataPro900 0.1.51, Spectrum 2, Lab Network, LabX, SEAL CSFAs, Agilent Baths.Ensure GMP environment systems and software validation and process compliance with internal policies and external (Data Integrity, FDA, ICH and MHRA) regulations. Ensure QC Systems and data comply with Data Integrity regulations.Provide support, advice and guidance to systems end users.Whilst the role is not specifically required to execute repair / maintenance work directly on / to the QC instrumentation / equipment / software, there is an expectation that the role will maintain a suitable level of technical competence to conduct or assistin identifying faults and causes to facilitate rapid resolution.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 Quality Management.
• Maintains reporting KPIs for equipment availability and issue resolution, develops other suitable KPIs and tracking systems to aid compliance and continuous improvement.
• Create, maintain and modify user accounts and passwords on GMP relevant application systems and IT infrastructure components.
• Create and maintain methods in Laboratory Computer systems.
• 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 QC, Engineering and service providers to schedule planned maintenance activities in accordance with SAP and maintain appropriate records and 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. Perform troubleshooting and monitor server space to prevent downtime and unexcepted failures.
• Works with QC Manager, 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 controllingspending.
• Leads QC instrument / equipment projects; raises relevant change control and validation documentation to support new instrument / equipment introduction / software implementation, 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 and through lifecycle of equipment / software.
• Provides functional support / technical guidance / advice to the Team Leaders and Senior Analysts within the QC Department as and when resource limitations demand.
• Raising and oversight of instrument / equipment / software based deviations and their subsequent investigation.
• Assists in laboratory investigations (LIRs) and deviation investigations where required.
• Communicate with Development Centre in the initiation of new items and products in the Quality Computer Systems
• Carries out other reasonable duties as and when required by Quality management.
• Represents the company at Customer, Internal, and Regulatory audits, interfacing directly with the auditors / inspectors where required.

Knowledge & 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 instrument / equipment qualification, validation, and change management
• Strong computer skills and knowledge of pharmaceutical quality systems such as, Empower and Trackwise.
• Knowledge of SAP regarding set-up of items and certification of test results
• Experience in project planning and delivery

Keyskills :
Equipment MaintenanceGMPLIMSPharmaceuticalCSV