Anand Kumar Jayala

Seeking a responsible and challenging position in CSV and IT Compliance where knowledge and experience can be shared and enriched. Senior Analyst with over a 10-year background in Computer system Validation.

• Involved in New Implementation such as e-QMS and electronic Clinical Software qualifications
• Involved in End-to-end testing and validation activities for Internal projects(Implementation of E-Sampling and E-Equipment handling web portals).
• Good Team player as a Lead in coordination with internal team and external clients.
• Involved in various Audit compliance activities related to Validation activities.

• Hands on experience for GxP, IT Validation and Compliance activities for various client projects in Life Science Industries.
• Involved in CVT (Compliance, Validation and Testing) activities, Involved in Compliance and CSV activities for SAP- EOL OS/DB Migration projects.
• Involved in Functional testing of LIMS application. Hands on experience in tools like TIMS, ADO for Requirement analysis and Testing
• Hands on experience in execution and documentation for Validation of Equipment’s and Testing instruments used in GXP environments.
• Involved in preparation and review of documentation with control points based on different phases of software as Build, Design, Testing which includes URS, Plans, Test Scripts, Reports as per V-Model and Agile Models.
• Involved in QMS activities documentation related to Risk Assessments, CAPA, Deviations with Clients and Internal Project teams.
• Involved in other Qualification activities such as BMS, Facility, Infrastructure Validations, HVAC and all Process and Testing Equipment Qualifications.