Experience

Aavis Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Associate

  • Mar 2020 - Present



Vitacoat corporation

• Production Supervisor / Validation Engineer

  • Aug 2018 - Mar 2020

  • Process Validation of different manufacturing processes and sub processes.• Executed Operational Qualification Protocol and cleaning validation for the tablet coating machine (Accela Cota).• Reviewed and updated current Quality Management System (QMS) of the company in compliance with the FDA 21 CFR Part 111.• Conducted Validation Deviation during Validation and found the root cause of failure using tools such as Cause and Effect and 5 Why’s after proper investigation and… • Process Validation of different manufacturing processes and sub processes.• Executed Operational Qualification Protocol and cleaning validation for the tablet coating machine (Accela Cota).• Reviewed and updated current Quality Management System (QMS) of the company in compliance with the FDA 21 CFR Part 111.• Conducted Validation Deviation during Validation and found the root cause of failure using tools such as Cause and Effect and 5 Why’s after proper investigation and defined a Corrective and/or Preventative Actions (CAPA) for the same. Worked closely with the investigation teams including Manufacturing and Quality Control Departments from initiating, reviewing, implementation, effectiveness and closing of CAPA.• R&D trials for Formulations of film coating solutions with disintegrants in coating solution itself and transferred it to plant manufacturing.• Employed Overall Equipment Effectiveness (OEE) and reduced performance loss.• Reviewed, updated and executed SOPs for operations, cleaning, maintenance and documentations.• Assisted during inspection of facility by FDA.• Maintained batch manufacturing records (BMRs).• Overseeing of operations, managing and reporting to the manager• Performed Quality Checks for final products. (weight, weight gain, friability, reactions) Show more Show less