Sunny Salunke

Successful Executive with over 7.5 years of demonstrated ability in delivering mission-critical results. Offering outstanding communication and cross-cultural team management skills. Responsible for Complete Computer System Validation, software related assessment, periodic review & validation activity

• Responsible for Complete Computer System Validation, software related assessment, periodic review & validation activity.
• Perform risk assessment in collaboration with development and testing team to identify, categorize, mitigate & follow through until remediation is complete.
• Responsible for Security assessment, 21 CFR part 11 as per guideline.
• Responsible for preparation of GMP document such as validation plan, test plan, requirement specification, functional specification, qualification protocols, test cases, summary report etc.
• Supporting the establishment and implementation of change control processes/requests relating to system development and Validation.
• Involved in GXP analysis, ERES Assessment, ALCOA++, Data Integrity.
• Preparation of Investigation of QMS events, CAPA, Laboratory incident, Deviation, Change Control in Track wise software.
• Facilitates the identification and development of Standard Operating Procedures related to Computer system validation.
• Good knowledge of 21 CFR Part11, GAMP 5, Quality System Impact Analysis, Validation scalability Assessment, Risk Based assessment.
• Participated in meeting with IT & validation team, in order to track project status & to verify the project progress complies with the project schedule.
• Initiation and closure of any deviations Ensure accuracy & completeness of test records.

• ELN (Electronic Lab Notebook)
• EMPOWER-3 ( By Waters for HPLC)
• LIMS (Laboratory Information Management System)
• OpenLab (By Agilent for HPLC)
• Borwin PDA (for HPLC)
• WinCats (For HPTLC)
• Spectramanager ( For UV)
• Oasis (For Sample, Data and Inventory Management

• HPLC (Agilent, Water, Jasco)
• UPLC (Waters)
• Particle Size Analyzer ( Malvern Mastersizer 3000)
• Liquid particle counter (Beckman Coulter)
• Karl Fischer Titrator (Metrohm), Coulometer: (Mettler Toledo)
• UV-Visible spectrophotometer (Jasco, LabIndia, Shimadzu)
• Osmometer
• Photometer