Zarafshan Ashfaq

Quality control team lead with 9+ years of GMP-regulated experience in pharmaceuticals and biotechnology, specialising in analytical sciences, technical problem-solving, and compliance. Proven track record in leading investigations, mentoring teams, and delivering process innovations that enhance quality, efficiency, and audit readiness with governance aligned to ICH Q9/Q10 and ALCOA+. Strong background in analytical chemistry and cross-functional collaboration, with expertise transferable to materials science challenges in inorganic chemistry, electrochemistry, and sustainable process development.

Passionate about applying scientific rigour and leadership to projects that deliver industrial and environmental impact.

Quality Control Team Leader - Fujifilm

(2023-01)

• Line manage 5 analysts (3 QC, 2 EM), delivering 1:1 coaching, career development plans, and performance reviews
• Track team performance against KPIs, site objectives, and right-first-time (RFT) targets and ensure all are met
• Ensuring end-to-end compliance with GMP in QC
• Manage scheduling and workload distribution using delegation, capacity planning, and cross training to balance demand
• Collaborated across departments (QA, RM, PD, Cell Assay) to support manufacturing milestones and financial targets
• QC inspection system lead for MHRA, FDA, internal, and customer audits, ensuring ongoing audit readiness
• Led complex investigations (change controls, CAPAs, hypothesis testing, root-cause analysis) using Lean Six Sigma, Go See (Gemba), and statistical analysis
• Own and lead continuous improvement projects
• Involved in recruitment and selection process

Senior Quality Control Analyst - Fujifilm

(2021-01 - 2023-12)

• Lead shift-based analytical support for manufacturing operations, ensuring cGMP compliance, data integrity, and high-quality output
• Own investigations, CAPAs, and LIs, including those arising from customer audits; deliver hypothesis testing, reports, and corrective actions
• Implemented process improvements such as increasing Right First Time (RFT) rates in endotoxin testing, presented at Quality Unit forum
• Directed Lean Six Sigma Yellow Belt project to close gaps in document archival, introducing new workflows and training, reducing risk of audit deviations
• Mentor analysts, providing technical training and career guidance, supported analyst progression to senior level
• Deputise for shift manager, attending Tier meetings, supporting decision-making, and ensuring smooth operations across the team
• Supported FDA and MHRA inspections as SME for TOC, pH, and endotoxin; contributed to audit readiness sessions and data gathering

Quality Control Analyst - Fujifilm

(2019-01 - 2021-12)

• Gained SME status in electrophoresis, UV, HPLC, UV, and endotoxin methods
• Delivered training and troubleshooting support to peers across microbiological and analytical techniques
• Strengthened team performance by guiding analysts through deviations, anomalous data identification, and technical problem-solving

Product Testing Analyst - MSD

(2017-01 - 2019-12)

• Conducted QC testing of raw materials, vaccines, and oral medicines using HPLC, GC, and dissolution techniques
• Ensured full GMP and SOP compliance, managing own workload while meeting project milestones
• Owned deviations and CAPAs, applying analytical thinking and risk assessment to maintain quality standards

MRes - Medical Genetics - Newcastle University (2017-01 - 2018-12)

BSc (Hons) - Biomedical Science - Northumbria University (2014-01 - 2017-12)