Andrew Hall

Senior Consultant, GxPAssure

Andrew Hall is a commercially astute pharmaceutical quality leader with more than 35 years’ experience across QC, QA and global quality operations. A Qualified Person since 2003 under EU Directives 2001/83/EC and 2001/82/EC, he is recognised by the HPRA and IMA. He holds a BSc (Hons) in Chemistry, a Higher Diploma and MSc in Pharmaceutical Manufacturing Technology, and is an MRSC and MIQA.

Andrew’s career spans medical devices, pharmaceuticals and biotechnology, with senior leadership roles at Mylan, MSD and Bioniche. He has led global quality strategy for complex products, established a greenfield vaccine and biologics fill-finish facility, and provided QP oversight for biologics, biosimilars, combination products and investigational medicines. His experience includes inspection readiness, regulatory hosting, quality governance, operational excellence, digital quality systems, validation, auditing and development of high-performing international teams.

Key Areas of Expertise:

• Provides EU QP certification and release expertise for biologics, biosimilars, combination products, investigational medicines and aseptically manufactured products.
• Develops quality strategy, governance, organisational structures, succession plans and cross-functional operating models across international manufacturing networks.
• Leads inspection readiness and confidently hosts and manages complex FDA, HPRA and other regulatory or customer inspections.
• Supports drug substance, drug product, sterile fill-finish, vaccine, biosimilar and final combination-product operations.
• Designs, assesses and strengthens cGMP and GCP systems, policies, procedures and oversight arrangements to sustain regulatory compliance.
• Brings hands-on expertise in process validation, analytical methods, calibration, QC laboratories, microbiology and laboratory optimisation.
• Conducts risk-based cGMP and GLP audits of manufacturing sites, contract organisations, suppliers, vendors and laboratories.
• Applies lean, SPC, FMEA, root-cause analysis and change management while coaching quality leaders and developing high-performing teams.