QC Senior Equipment Technical Specialist in Hatfield

Job Description QC Senior Equipment Technical Specialist (Temp) Hertfordshire, UK – On Site / 100% 1-year contract – PAYE This role is responsible for supporting all Quality Control (QC) laboratory equipment and associated electronic systems throughout their full lifecycle. The position supports technical developments within the QC laboratory environment and oversees third‑party contractors to ensure operations are conducted in line with internal procedures, current Good Manufacturing Practice (cGMP), and applicable regulatory expectations. The role ensures that QC laboratory systems and software used to support the manufacture, testing, packaging, storage, and distribution of marketed drug products remain compliant with GMP, data integrity, and corporate quality requirements. Key Responsibilities Support and deliver qualification and validation of QC equipment, processes, and electronic systems in line with internal procedures, GMP, and GAMP guidelines. Provide input into the drafting, review, and approval of quality policies, systems, and procedures related to QC equipment and systems. Ensure QC laboratory systems and software remain in a qualified and compliant state. Act as a strong advocate for data integrity principles across all systems and equipment. Support procurement of new laboratory equipment and software, including forecasting for replacements and upgrades. Coordinate and lead equipment servicing, calibration, repair, and maintenance activities. Manage relationships with external vendors and service providers, including technical support and helpdesk services. Coordinate vendor site visits, raise purchase orders, and ensure accurate traceability of equipment documentation (e.g. service reports, calibration certificates). Support ongoing operation, maintenance, and improvement of manual and electronic systems. Coordinate with internal IT teams to ensure systems align with corporate IT and quality policies. Manage system updates and upgrades, ensuring continued qualification. Ensure procedures are in place and followed for data backup, archiving, retrieval, and access management. Lead and manage QC equipment and software projects internally. Support and raise change controls to ensure qualification and validation requirements are addressed. Maintain equipment and project trackers to ensure visibility, scheduling, and compliance. Support review and approval of commercial off‑the‑shelf (COTS) documentation. Provide technical support and troubleshooting for QC analysts and system users. Prepare and update SOPs and training materials related to equipment and systems. Support investigations related to equipment issues, deviations, CAPAs, and incidents. Complete maintenance and work orders in a timely manner. Communicate equipment‑related updates clearly to all stakeholders. Ensure all activities are performed in line with GMP, GDP, internal quality systems, and industry standards. Maintain a safe working environment and report incidents and near‑misses in line with procedures. Ensure product quality through adherence to approved processes and documentation. Identify opportunities for continuous improvement, efficiency, and innovation. Maintain strong communication with internal stakeholders and external partners. Perform duties in line with role objectives, behaviours, and competencies. Skills & Qualifications Strong knowledge of QC laboratory equipment qualification and validation. Working knowledge of computerized system validation (CSV) and GAMP. Good understanding of GMP, data integrity, and regulatory requirements. Experience with analytical software, electronic QC systems, and quality systems. Ability to analyse user requirements and drive system improvements. Strong communication skills with the ability to translate technical concepts clearly. Sound technical and scientific judgement. Proficiency with standard office software (Word, Excel, PowerPoint). Strong experience with QC laboratory equipment qualification and validation. Working knowledge of CSV, GAMP, GMP, and data integrity requirements. Experience supporting analytical software and electronic QC systems. #J-18808-Ljbffr