Mushandan Balasubramaniyam

• Executing qualification processes (FAT, SAT, DQ, IQ, OQ, PQ) for pharmaceutical equipment and utility systems. • Preparation of GMP-Documents (URS, FMEA, Qualification plans and reports). • Preparing equipment/system specific qualification timelines. • Ensuring adherence to both local and global compliance standards • Handling the documentation and resolution of Change Controls, CAPAs, and deviations. • Engaging with project stakeholders and carrying out routine operational tasks.

• Executed multiple projects in the pharmaceutical and healthcare industry. • Managed cross-functional teams and coordinating with vendors, suppliers, and external stakeholders. • Developed comprehensive project proposals. • Familiarised and implemented regulatory requirements and quality management systems • Prepared and executed qualification documentation (FAT, IQ, OQ) for the respective equipment/system. • Supervised equipment delivery to site and the subsequent installation procedures.

Toxicology, Waste water treatment, Solid waste management, Biopolymer and biofuel, Genetics

Prozeßsteuerung, Erneuerbare Energienumwandlung, Biogaserzeugung und Analyse in Laboratorium, Sicherheitstechnik, Chemieingenieurwesen

Chemistry, Process design and controls, Plant design and simulation, AutoCAD, Aspen HYSYS, COMSOL, Distillation design,