Sunil Kumar Dubyala Email & Phone Number

California, United States

• Initial qualification of laboratory instruments (Next in Use systems) including Qualification Report writing.
• Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
• Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs.
• Drafted testing Summary Reports, Validation summary report.

Illinois, United States

• Documented various validation deliverable of system life cycle as required by FDA regulations under 21 CFR Part 11.
• Reviewing the User Requirement Specification (URS) and the Functional Requirement Specification (FRS) document and analyzing the causes leading to discrepancies and failure of the pre-executed OQ scripts.
• Created design verification protocols/reports and test method to ensure each claim has supporting evidence in the DI-IF.
• Involved in creating test bed to check the Installation and Operational Qualification (IQ/OQ) for the application.

Ohio, United States

• Developed validation documents including Validation Protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for Empower Software implementation.
• Reviewed and discussed Business Requirements and System Requirements with Business Analyst (BA), Project Manager (PM), IT Team members and End Users.
• Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP Analysis...

Hyderabad, Telangana, India

• .. Performed Test validations procedures, for dialysis machinery. Generate and execute validation test protocols and testing's. Conducted CAPA, continuous improvement, audit, quality systems and assurance, etc.
• Expertise in writing and executing Validation Protocols and authoring Reports (IQs, OQs and PQs). Supported CAPA Remediation process by reviewing retrospective supplier CAPAs for completeness to address CAPA plans.
• Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP and process mapping.
• Experience in Reviewing/Writing/Updating current operating procedures and developing new Standard Operating Procedures (SOPs) and train users on SOPs for many analytical instruments and manufacturing methodologies.