Associate Manager Validation
Current- Areas of Validation under my responsibility are,- Equipment Qualification (Sterile and Non-Sterile)- Utility Qualification- Facility Qualification- Computer System Validation- Thermal MappingDescription of.
- Review User Requirement Specifications (URS), perform Factory (FAT) and Site (SAT) Acceptance Testing, conduct Design (DQ), Installation (IQ), Operational (OQ), and Performance (PQ) Qualifications for GMP utility.
- Execute Computer System Validation for systems impacting business processes, complete risk and impact assessments based on GAMP 5 guidelines.
- Write and execute qualification protocols including IQ/OQ and PQ, develop relevant procedures and set acceptance criteria.
- Handle change control documents, manage deviations, conduct investigations, and oversee CAPA procedures.
- Review preventive maintenance SOPs for equipment and systems, assist with corrective maintenance tasks.