QA Lead

Company Description: Medifarma Laboratories is a toll manufacturing pharmaceutical company based in Indonesia. Its head office is in Depok, on the southern outskirts of Jakarta, Indonesia's capital. Founded in 1975, our production facility is currently 36,595 sqm. Our production facility and operations have been certified by Indonesia NADFC (National Agency of Drug and Food Control), with the standard of manufacturing practice found to be in accordance with the current standard of Good Manufacturing Practices as well as to meet the standard required by Pharmaceutical Inspection Co-operation Scheme (PIC/s) and World Health Organization (WHO).

Job Description:

• Providing input to the QA Manager in making the Validation Program and matters related to Validation for the preparation of Budget Quality Assurance.
• Prepare process validation protocols and reports for the production scale and pilot scale for existing products, validate procedures for cleaning equipment and machines.
• Coordinate with related Supervisors in carrying out Process Validation, Validation of equipment and machine cleaning procedures, and Validation of Supporting Facilities.
• Coordinate with the IT Department in preparing and implementing computerized system validation.
• Monitor the implementation of sampling, testing, and inspection during the validation process in accordance with SOP.
• Responsible for conducting CPOB self-inspection in the area of PT Medifarma Laboratories.
• Maintain Change Control and Quality Deviation Report (QDR) documentation.
• Coordinating and tracking CAPA related to audits, change control, and QDR.