Olquidia Ramirez Garcia

Senior QC & Analytical Specialist with 10+ years of experience in GMP pharmaceutical laboratories supporting APIs, intermediates, finished products and stability testing. Strong expertise in HPLC/GC analytical techniques, analytical troubleshooting, investigations (OOS/OOT/OOE), GMP documentation and data integrity. Experienced in reviewer activities, analytical transfer, laboratory coordination and cross-functional collaboration.

Since 2025 acting as Stability Team Leader and supporting instrument systems validation, CSV activities and GMP computerized systems compliance, including risk assessment, SOP authoring and 21 CFR.

Senior QC & Analytical Specialist - Stability Team Leader, Validation & GMP Systems at OLON S.p.A. (2025-07 – Present)

• Team Leader for the Stability Testing analytical group, with technical and operational coordination
• Workflow planning, prioritization, technical guidance, review support, troubleshooting and escalation handling
• Instrument systems evaluation, supplier assessment and coordination between vendors and external validation agencies
• Qualification/validation support, SARA preparation, risk assessments, CSV support and GMP computerized systems activities
• Definition of GMP and 21 CFR Annex 11; SOP/Work Instruction authoring; ADIUTO training qualification

Senior QC Analyst - Reviewer & Laboratory Support at OLON S.p.A. (2020-01 – 2025-06)

• Reviewer activities for GMP analytical documentation and investigations
• Technical and operational support to the Laboratory Manager, including decision support and escalation handling
• Training/onboarding of QC analysts, analytical transfer support, release timeline coordination and continuous improvement

Senior QC Analyst - Investigations at OLON S.p.A. (2018-01 – 2020-12)

• OOS/OOT/OOE investigations, deviations and LIR documentation
• GMP analytical documentation review, QA collaboration and analytical troubleshooting

QC Analyst at OLON S.p.A. (2015-05 – 2018-12)

• GMP QC analyses on APIs, intermediates and finished products
• HPLC / GC / physicochemical testing; SOP execution and release support

Post-Secondary Specialization in Industrial Pharmaceutical Process Techniques – ITIS S. Cannizzaro (2014-09 – 2015-07)

High School Diploma in Chemical Technology – I.T.C.S. "Primo Levi" (2009-01 – 2014-12)