Projects

 Supported the configuration, qualification, and deployment of Automation Control Sysems (DCS), PLCS/SCADA and Manufacturing Execution Systems (MES) within large-scale biologics operations. 

 Computer System Validation activities for GMP manufacturing systems, ensuring alignment with Commissioning, Qualification, and Validation (CQV) processes. Oversaw integration of DCS, SCADA, MES, and OSI PI systems into a harmonized validation framework using GAMP 5 & Annex 11 principles. 

 Supported biosimilar development activities and technology transfer across CMOs, with documentation aligned to EMA and FDA expectations. 

  Supported CSV and remediation Plan-Led audit readiness and remediation plan for laboratory and manufacturing systems.

QA support for Dydrogestrone Expansion, and OPEX processes.

IGJ Audit readioness including remediation plan and participation in front office during audit.

Supported remediation plan and audit readiness.  Conducted comprehensive ISO 17025 audits for analytical laboratories, with a focus on data integrity, instrument qualification, and method validation. 

 Supported validation of manufacturing systems and compliance of legacy equipment with new data integrity requirements. 

Supported Quality unit in the OPEX project.

GMP Compliance Oversight , Ensured that all activities adhered to EU GMP, FDA 21 CFR, ICH Q10, and local regulatory standards.