Experience

Sun Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Computer System Validation / Administrator

  • Sep 2017 - Present

  •Manage Computer System Validation Projects of GxP application and Managing Software Implementation and development life cycle Management •Prepare the Validation plan, Risk Assessment plan and performed functional risk assessment per applicable compliance with GAPM 5, quality risk management and predicate rules pertaining to concerned regulatory agency. •Implementation of the Quality Lab Computerized systems validation such as Empower, LAB X, Tiamo, FTIR, UV –Spectrophotometer Malvern, PharmSpec, Syngistix, Valquest software and firmware based equipment •Experienced in the computerized system Asset Management , Legacy computer validation process, Firmware base equipment qualification / validation as per regulatory requirement •Implementation of Various Robotic Automation Process (RPA) projects for the Quality system Management to improve IT and Business service without compromising the quality and compliance. •Maintain the GxP IT system in to the Validated state during the life by performing the Periodic Review process of validation in define interval •Excellent interpersonal, organizational, verbal and written communication skills and good time-management skills.



OHM LABS, INC.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Equipment Qualification / Laboratory service

  • Sep 2014 - Sep 2017

  •Drive and Support the successful operation of Quality Calibration Management System Life cycle and business Functions as unit sites through interaction with internal as wells external service provider.•Troubleshoots network operation system, LAB systems (GMP, Non-GMP), related software, and hardware issues, Works with trouble ticket system for a documentation trail, Runs diagnostics on computer hardware.•all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory, 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments•Maintain up-to-date knowledge and administrative controls of quality equipment system requirements as they apply to computerized system in accordance with cGxP’ s regulations, GAMP, industry standards, policies and procedures.

• Cleaning validation Analyst

  • Sep 2010 - Sep 2014

  •Author and execute all cleaning validation Standard Operating/Test Methods (STM), new product launch cleaning Validation Planning and analytical cleaning method optimization, validation and process equipment cleaning validation protocols and summary reports for validated methods.•Experience in CIP/COP and manual cleaning activities, troubleshooting CIP system failures, optimizing CIP/COP systems including manual process and CIP equipment, developing SIP/CIP/COP cycles.•Established and determine sampling locations (difficult-to-clean, functional locations and material-of -construction) for manufacturing process Equipment and Responsible to perform visual inspections and collecting swab/Rinse sampling with executed matrix-based acceptance Criteria (MACO Limits) based on cleaning ability, toxicity, potency and solubility of API and Detergents.•Established DEHT (Dirty Equipment Hold Time) and CEHT (Clean Equipment Hold Time) studies for worst-case active ingredient.•Supporting role in a Process Validation team to execute new commercial product launches, Tech-Transfers, Site Transfers, Process improvements manufacturing of exhibit batches & Scale-up batches.



Sun Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Analytical R&D Analyst

  • Mar 2009 - Aug 2010

  •Performed Assay and Degradation products, Uniformity of dosage units and Blend uniformity by HPLC, Dissolution by UV and HPLC and Water content by Karl Fisher, Disintegration and TLC, Tapped Density, Bulk Density for In-process, finished products & Stability samples as per required. •Performed in–House standard qualification, instrument calibration and preventive maintenance of Dissolution apparatus, HPLC, UV/VIS and PH meter. •Maintain proper documentation in accordance with the CGMP Regulations. •Responsible for maintaining Lab Not Books and documents for the assigned projects.