Joel Galang

About Joel,

Joel is a Chemical Engineer with 26 years of pharmaceutical GMP experience in the areas of engineering, quality, computer system validation, manufacturing and distribution.
His practical experience includes:

• GxP Computerised System Validation (CSV) specialist with deep expertise in designing and executing risk-based, audit-ready validation frameworks that align with global regulatory expectations (FDA 21 CFR Part 11, EU/PIC-S Annex 11, GAMP 5), ensuring data integrity, patient safety, and sustained inspection readiness across complex enterprise and automation systems.
• Experienced in vast aspects of quality assurance and manufacturing for highly regulated pharmaceutical industry. Expertise in all areas of Quality Assurance processes and in managing quality systems while maintaining compliance with regulations. Proficient in setting-up, establishment and implementation of quality systems in diverse disciplines.
• Proficient in process engineering in pharmanceutical manufacturing.
• Highly skilled to perform process and system validation in accordance with Good Manufacturing Practice (GMP) regulation. Specialised in GMP and computerized system and data integrity regulations.
• In-depth knowledge and experience in design, implementation, management, such as master data and processes of ERP systems (e.g. SAP, Jeeves, etc…)
• Adept in all GxP regulations such as GCP, GLP, GMP, GDP and GPP, both global and regional.
• Implementation and validation of laboratory instrument/equipment. Integration and validation of chromatography data system (CDS). Implementation and validation of Laboratory Information Management System (LIMS).
• System knowledge: Distributed Control System (DCS) operation, Process Control Systems (with electronic batch documentation), Data Acquisition System (LAN Based Process Automation), Personal Computing/Programming, Web Design and Networking.

Joel is a qualified Quality Auditor with experience in petrochemical, pharmaceutical and food (F&B) industry.