Manjula Ghosh Allergan

Manjula Ghosh has 27 years of extensive expertise in all aspects of Microbiology and Aseptic Processing, Quality Assurance, Quality Engineering and Validation.
She has designed highly successful and compliant Environmental Monitoring and Aseptic Process Simulation programs and implemented the validation plan for new clean rooms (ISO 5, 6 and 7), isolator systems and pharmaceutical water systems.

Manjula is an expert in the validation of sterilization and depyrogenation processes, cleaning validation, computerized systems and new equipment.

She is knowledgeable in all aspects of Microbiology method validation and compendial and regulatory requirements and guidance. 

Manjula is a senior Quality leader skilled in Verification and Validation (V&V), Good Laboratory Practice (GLP), Change Control, Validation of new products/ processes, and end to end Life cycle management, Investigations, CAPAs, Change controls, risk assessments.