Ensuring that all factory operations run smoothly to produce products that meet quality standards and regulatory requirements, with high productivity in a safe and healthy work environment. Ensuring the quality organization implements, maintains, and improves compliance with the latest Good Manufacturing Practices (GMP) to serve the supply chain with high-quality products that meet predetermined specifications and are delivered on time. Reviewing and approving the design of new buildings and facilities, or changes to existing designs. Responsible for overseeing the Quality Assurance, Quality Control, and Quality System & Compliance departments.Job Description :1. Lead and manage the entire manufacturing process of radiopharmaceuticals, ensuring timely and efficient production while maintaining product quality and compliance with regulatory requirements.2. Ensure full compliance with local and international regulations, including GMP, environmental, health, and safety (EHS) standards, and radiological safety requirements.3. Implement continuous improvement strategies and lean manufacturing principles to enhance operational efficiency and reduce production costs.4. Oversee radiation safety protocols and ensure all safety procedures are followed, protecting staff and the environment from potential hazards.5. Collaborate with cross-functional teams such as R&D, regulatory affairs, and supply chain to align production goals with business objectives.6. Troubleshoot operational challenges and address any issues related to production, equipment, or regulatory compliance swiftly and effectively.

Ensuring the implementation of Project infrastructure, Manufacturing technology, Computerized System Validation (CSV), as well as audits related to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in Kalbe Group Manufacturing according to local and international standards and appropriate regulations, in order to improve process quality and products and make Manufacturing Kalbe Group a "Manufacturing of Excellence"Job Description :1. Ensuring the implementation of infrastructure projects (Facilities, Utilities, and Machinery/Instruments) at Manufacturing Kalbe Group and participating in project document reviews, such as the Feasibility Study (FS), Construction Drawing, and Summary Evaluation Project Report, to ensure project feasibility and compliance with appropriate standards and regulations2. Ensuring that the implementation of Manufacturing technology (Machine System and Automation) at Manufacturing Kalbe Group complies with appropriate standards and regulations and participates in project document reviews, such as the Feasibility Study and Summary Evaluation Project Report, to assess the impact and benefits of implementing new technology3. Ensuring the implementation of the Digitalization System Assurance in the Kalbe Group Manufacturing System follows the phases of Computerized System Lifecycle Management4. Ensuring that the implementation and application of Computerized System Validation (CSV) at Manufacturing Kalbe Group complies with appropriate standards and regulations5. Become an initiator in creating a "Manufacturing of Excellence" culture in site operations throughout Manufacturing and Warehousing in the Kalbe Group6. Participate in the implementation of quality audits related to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Computerized System Validation (CSV) and ensure compliance with applicable standards and regulations during quality audits

Ensuring effectiveness, productivity, efficiency and compliance with regulations, quality standards and policies regarding the implementation of Manufacturing Execution System related to manufacturing in Kalbe GroupJob Description :1. Prepare and monitor Manufacturing strategy and roadmap in Kalbe Group but not limited to Manufacturing Execution System through adoption and implementation of Digitalization and Data Integration2. Facilitate the planning, implementation and evaluation of the Manufacturing Execution System at Kalbe Group by adopting existing technology or digitization systems3. Support project management related to measuring, supporting and approving technical aspects for new facilities and utilities4. Ensuring the implementation of the Manufacturing Execution System carried out by each entity in the Kalbe Group in accordance with the regulations, quality standards and policies set by the Kalbe Group5. Facilitate and provide support to entities that need assistance in implementing or dealing with problems related to Manufacturing Execution System

Ensure & improve quality implementation in Kalbe by performing audit based on Internal & External Regulation.Job Description:1. Arrange and run Audit Program in Kalbe Group (vendor audit RM-PM, toll manufacturing, distributor, principal, vendor and etc)2. Create on-site audit report & audit questionnaire3. Ensure CAPA are implemented by auditee4. Review & update Kalbe Corporate Quality Manual & Guideline of Quality Assurance5. Conduct gap analysis & ensure alignment of quality procedure in Kalbe Group subsidiaries6. Monitor & analyze Quality Compliance KPI in Kalbe Group subsidiaries

Additional responsible as Regulatory Conformance Supervisor to assist in obtaining and maintaining government approval for drugs and related materials and also work in government or lawJob Description:1. To prepare and ensure document for register submission comply with document and current practice in GMS factory2. To prepare, coordinate and provide document for submission to local FDA and MOH related with Drug Products GMP License, Manufacture License and Registration Requirements3. To prepare conformance registration detail and observe and tracking any gap found during preparation of conformance to registration details4. To check and maintain Drug Products GMP License and Manufacturer License are valid5. To ensure regulation from Local FDA (BPOM) and local MOH are implemented

Responsible for ensuring a product meets the established standards of quality including reliability, usability and performance required for distribution and the marketJob Description:1. To assist OQ Manager and OQ Lead in handling non-conformance in Manufacturing, Laboratory, Facilities, Utilities, Warehouse and Product distributions2. Real time review of incidents, issues and events in manufacturing to determine the correct incident categorization, investigation and Quality approval3. To review of GMP failures and any other failures in the process or quality systems on site to ensure the appropriate investigation is triggered as soon as practical4. To provide Quality oversight and real-time assessment of planned and unplanned changes to processes and quality systems to ensure Quality approval prior to change implementation5. To support customer complaint investigation assigned by OQ Manager

Responsible as Warehouse Supervisor to tracking and coordinating the receipt, storage, timely delivery of goods and materials, checking orders, items received, inventory and deliveries for accuracyJob Description:1. To organize, coordinate and supervise all daily activities in the Warehouse starting from inbound activities, transfer materials for supplies, outbound activities2. To ensuring compliance with Quality and EHS is carried out by all WH team members3. To lead and coordinate the investigation process related to irregularities or incidents or customer complaints4. To conduct risk assessments in the WH area both from the aspect of Quality or Safety5. To support stabilization new system SAP at Warehouse governance

Responsible for processing claims, negotiating settlements, verifying insurance coverage and reviewing insurance casesJob Description:1. To verifies patient eligibility also review claims and supporting documents submitted by providers2. Adjudicates claims in accordance with rules and regulations3. To verifies services were authorized and calculates payments using contract or rate guidelines4. To performs general clerical tasks in support of the programs5. Types a variety of forms and documents also inputs data into computer system

Responsible to helps companies and brands understand what sells by analyzing market data on a local, regional or national level and determine gaps are within the marketJob Description:1. To preparing, planning and project managing the publication of all publicity material to maximize brand promotion2. To creating and developing new innovative ways to communicate the company message to existing customers3. To planning and project managing marketing events and evaluating their success4. To supporting the marketing manager in day to day marketing activities5. To plan, develop and deliver campaigns as agreed within timescales