Sai Sandeep K

Experience

1. Process Validation Engineer

   Alcon Industries, Inc

   Jun 2023 — Present · Houston, TX, US

   Followed Computer Systems Validation (CSV) Master Plan to author, review and approve (CSV) deliverables for systems as per GxP (GLP, GCP, and GMP) FDA Assessment• Profound knowledge in pharmaceutical/medical device regulations like FDA 21 CFR Part 11, FDA 21 CFR part 820 and ISO 13485• Involved in the creation of Validation Plan, Verification Protocols and Verification Summary report documents• Performed Routine analysis of raw materials, in-process and finished pharmaceutical dosage forms, products on stability using different instruments such as HPLC, UPLC, Dissolution, laser diffraction, Particle size analyzer like Malvern Mastersizer and Horiba, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, TLC• Acted as HP ALM admin and was responsible for uploading requirements into HP ALM• Equipment validation and Technical documentation as per FDA/ISO 13485 and GAMP regulations• Maintained CAPA procedure, initiated investigation of non-conformances through root cause analysis (RCA), evaluation of the effectiveness of CAPA process, and initiation of action as required improving effectiveness• Analyzed test scripts to be compliant with 21CFR Part 11 regulations, maintaining validation Electronic records and following relevant SOPs• Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts using HP ALM and executed them. Executed validation test cases based upon system requirement and FDA standards. Tracked and closed the defects using HP ALM• Provided systems engineering input, including requirements development and risk Validation assessment, for Design history file (DHF) remediation and new product development (NPD)

Education

• CMR College of pharmacy

  Bachelor's degree, Pharmacy

• Sacred Heart University

  Master's degree, Healthcare Informatics