Sandra Tirado

• Carry out field service activities including instrument repairs, preventive maintenance, qualifications and installations, including IQ/OQ, for GC and FTIR instrumentation and accessories. • Issue GMP reports for regulated activities and client service reports using ServiceMax. • Support customers through onsite user training for defined product groups. • Promote and sell instruments and service products, including consumables and service contracts.

• SME & Team Lead for method VVT to ICH, GMP and Pharmacopeia. • Analysts supervision & VVT project and workload management. • Installation, verification & troubleshooting of new instruments and IQ/OQ/PQ. • Protocols/reports/CoAs/SOPs/submission documents issuing, reviewing, approval, documentation for new pharmaceutical products. • GMP data review and OOL/OOS investigations. • Interviewed candidates and trained and supervised analysts. • International & RA meetings.

• Method VVT to ICH, GMP and Pharmacopeia. • VVT & Routine Projects and clients management. • Prepared and issued enquiries, protocols, reports and Certificates of Analysis; checked GMP data and interpreted results. • Phase 1A/1B OOS investigations. • Complex GC routine & VVT pharmaceutical analysis. • Analytical and technical troubleshooting, GC-MS and wet chemistry. • Trained and supported junior staff and delivered internal/external presentations.

• Performed complex routine analysis of food, pharmaceutical and healthcare samples using GC techniques under minimal supervision, following study protocols and Pharmacopeia requirements and working to GMP and UKAS standards. • Reported results manually and through LIMS, Q-Pulse and OpenLab. • Troubleshooted instrumental and analytical issues and supported junior staff. • Managed projects and clients and cross-trained in GC-MS and wet chemistry to support workload requirements.

• Performed routine analysis of food, pharmaceutical and healthcare samples using gas chromatography, following study protocols and Pharmacopeia requirements and working to GMP and UKAS standards.

• Performed routine analysis of soil, manure and slurry samples using thermogravimetry, DUMAS combustion, TOC analysis and wet chemistry procedures.

• ISO 9001:2008 and ISO 17025 quality systems, including audit preparation, documented procedures, laboratory quality documentation and method accreditation. • Internal audits, equipment calibration/maintenance and method and equipment validation. • Physical-chemical and microbiological testing, reporting to SOP'S and laboratory quality requirements. • Equipment calibration, maintenance and method validation, and liaised with customers, regulatory representatives, staff and suppliers.

• Performed physical-chemical and microbiological testing, reporting and calculations in accordance with documented procedures and laboratory quality requirements. • Supported equipment calibration, maintenance and method validation, and liaised with customers, regulatory representatives, staff and suppliers.