K. Raghavendra Reddy

Highly motivated QA professional with 12 years of experience in Commissioning Qualification and Validation of Greenfield Projects and Revalidation and Computerized System Validations in Sterile Pharmaceutical and Biologics Industry.

• Participated in the Successful completion of equipments commissioning qualification and validation activities pertaining to JHONSON & JHONSON COVID-19 Facility.
• Successfully Completed Commissioning Qualification and Validation of Vial and Ampoule Filling Lines.
• Successfully Completed Commissioning Qualification and Validation of Drug Substance Facilities.
• Successfully Completed the Commissioning Qualification and Validation of Dengue Vaccine (Takeda) Manufacturing Equipments.

• USFDA
• MHRA
• EUGMP
• WHO
• ANVISA

• Review of Concept & Scope documents, conceptual layouts and basic design documents like Zoning layouts, Room assumptions and room books.
• Qualification of Automated systems – BMS, EMS, IBMS (FAS, PAS, CCTV, DIS, BA)
• Qualification of Clean Rooms, UDAF's, BSC units and associated unidirectional airflow units.
• Review of design documents of unit systems and facility layouts.
• Qualification of clean utilities & process Equipments.
• Review & approval of qualification life cycle documents like URS, DQ, DS, FS, FAT, SAT, IQ, OQ, PQ and RTMs.
• Preparation / Review of the Facility, Equipment and Utilities Qualification protocols (IQ/OQ/PQ), compilation of the executed protocol and preparation of report.
• Perform investigations related to qualification failures and closure of QMS elements within the agreed timelines.
• Support operations team for development of equipment operation and system SOPs.
• Review Finalization of Functional risk assessment of critical equipment's.
• Co-ordination with cross functional department like Engineering, User/Production, Validation Group, Maintenance, QC etc., for effective flow of qualification activities.
• Ensure quality systems/aspects with respect to qualification are implemented.
• Impart training to sub-ordinates for operation of data loggers, report preparation, review of executed qualification documents.
• Computerized system validation (CSV) Life cycle (21 CFR PART 11, EU Annexure -11 & GAMP 5).
• Adhere to data integrity principles.