Trisiana Sarwastuti

Experience

• 

  PT Triyasa Nagamas Farma

  May 2011 - now

  Responsible for ensuring the product quality and detect deviations through various tests for starting material, intermediate, and finished product.Detail :• Releasing or rejecting starting material (raw material and packaging material) before use to manufacturing.• Make a comply or not comply decision for inspected intermediate and finished product.• Coordinate the examination and report of supporting utility including its trend analysis.• Ensuring that all tests are carried out according to approved method and all instruments used for analysis have been calibrated, and other support aspect has been qualified.• Responsible for implementation of stability study for new producst, validated products, and routine products in accordance with applicable procedures. • Responsible for implementation of room monitoring including its trend analysis.• Colaborate with related department to conducting validation project.• Participate in the investigation of deviation that occur. Show less Responsible for ensuring that the final product observes the company's quality standard.Detail :• Coordinate the calibration program and external analysis.• Coordinate sampling process for raw material and packaging material that will be used for manufacturing.• Checking and ensuring the suitability of the batch record during the processing.• Checking and ensuring the implementation of room monitoring, sanitation, instrument verification, and in process control monitoring.• Follow up for releasing raw material, bulk and finished product.• Managing sampling of retained and stability sample.• Handling customer complaint.• Handling non conformity of quality system.• Coordinate the implementation of CAPA (Corrective Action and Preventive Action) for Customer Complaint Handling, Deviation Handling and Audit Finding.• Handling change control.• Colaborate with related department to preparing risk assessment related quality system.• Contribute to internal audit and supplier audit. Show less

  • Quality Control Manager

    Apr 2020 - now

  • QA Supervisor

    Sept 2014 - Apr 2020

  • Quality Assurance Staff

    May 2011 - Sept 2014