Kaushik Suhagiya Email and Phone Number

● Result driven professional working in Pharmaceutical Industry having 14+ years of experience in Paperless system implementation – GxP system, Audit & Compliance, Quality Assurance, Qualification & Validation, Green field project.● SME for Sterility testing, Microbial limit test, Bacterial endotoxin test and Environment Monitoring program.● Contamination control strategy, Microbiology annual assessments including EM position rationale, alert limit review etc.● Project support/ establishing key requirements and quality aspects for all Microbiology related projects.● Provide SME support for customer and regulatory audits.● Identifying, Planning and implementation of validation requirements and routine analysis in a cGMP Environment.● New facility laboratory setup, Equipment / Instrument qualifications in line with GxP requirements.● GxP system qualification - URS, System assessment, Configuration specification, Qualification summary report.● Handling of QMS (Non-conformance, RCA, CAPA, Risk assessment, Change control).● Change management including IT.● Review of audit trails.