Hendry Hermanto

• Lead and manage Quality Assurance Department with 1 supervisor and 2 staffs.
• Set up quality management system and qualification & validation system for new oncology factory until established.
• Set up Quality Policy and Quality Culture including preparation of Quality Manual for new oncology factory.
• Preparation of Site Master File and Validation Master Plan for new oncology factory.
• Create and review Quality Management System procedures such as preparation of SOP & WI, Documentation Management System,
  Change Management, Training Management, etc.
• Manage and monitor the qualification activities and documentation.
• Assist Director to set up quality control laboratory.
  Lead, manage, and monitor the GMP certification preparation for new oncology factory.
• Manage and maintain the quality management system implementation after received GMP certification from BPOM.
• Support the development team for dossier submission until received marketing authorization.

Achievement:

Successfully delivered the factory team to receive the GMP certificate from BPOM with no critical finding and only once CAPA review.

• Lead and manage Quality Assurance Department with 4 QA Specialists and 1 QA Administration.
• Manage QA Operations task such as batch review and disposition, review and approve investigation (deviations, OOS/OOT, complaint),
  review and approve PQR Report, create and/or review Quality Risk Management Report, handle of product return and recall including
  perform routine mock recall.
• Lead and manage QA Shopfloor activities.
  Manage and monitor of packaging material development until implementation.
• As QA SME review for qualification and validation documentation.
• Lead and monitor Data Integrity Remediation Project.

• Lead Logistic (Warehouse & Dispensing) Department with 2 supervisors, 4 coordinators, and more than 30 warehouse and dispensing
  operators.
• Manage and monitor of pharmaceutical warehouse for raw material, packaging material, finished goods, and supporting material.
• Manage and monitor dispensing activities.

• Lead Validation Department with 2 supervisors, 3 senior staffs, 5 inspectors, and 1 administration.
• Lead and manage calibration, qualification, and validation activities at factory.

Manage and handle calibration, qualification, and validation activities at factory.

Manage and handle process and cleaning validation activities, stability of product, reporting of product quality review, and product
complaint at factory.