Quality System Staff

Company Description: Established in 2014, PT Etana Biotechnologies Indonesia (Etana) is an emerging producer of high-quality, affordable and innovative biopharmaceuticals to treat a range of metabolic, autoimmune and other major life-threatening diseases, including cancer. In order to best serve Indonesian patients, Etana has established a network of strategic alliances and partnerships with international pharmaceutical producers with a strong track record in researching and developing safe and efficacious pharmaceuticals, enabling Etana to offer new treatments to the Indonesian market. At the same time, Etana is working to build Indonesia’s human resources and its own research and production capabilities by establishing environmentally-friendly, multi-purpose biopharmaceutical manufacturing and research facilities, staffed by top graduates from Indonesia’s foremost medical research and educational institutions. Job Description:

• Enforce data integrity policies and standard operating procedures (SOPs) across Technical Operation team and ensure alignment with regulatory standards such as GMP, FDA, and WHO requirements in all data practices.
• Lead routine audits and assessments to evaluate compliance with data integrity practices.
• Collaborate with IT and Quality Assurance teams to establish, implement, and maintain robust policies, validation, monitoring, training, and continuous improvement processes that ensure data integrity throughout the lifecycle of computerized systems.
• Monitor and oversee data handling, recording practices, and access permissions to ensure adherence to data integrity standards, maintain data security and traceability, and address any discrepancies in access or recording practices.
• Identify any gaps or potential risks in data handling or documentation and develop corrective actions as necessary and document audit findings and report these to management, along with recommendations for improvements.
• Collaborate with Training and Competency Development Team to plan and conduct training sessions and workshops to build awareness of data integrity principles among Technical Operation team.
• Identify opportunities to improve data governance, accuracy, and compliance, collaborate with relevant teams to implement initiatives that enhance data integrity practices, and support the development and revision of policies, procedures, and training materials to align with updated industry standards.
• Support the creation and revision of Standard Operating Procedures (SOPs), work instructions, and other quality-related documentation to ensure clarity, accuracy, and compliance with regulatory requirements.
• Participate in initiatives to continuously improve the Data Integrity by identifying inefficiencies or areas for enhancement and providing input on process improvement.
• Collaborate with cross-functional teams to implement best practices and ensure a culture of continuous improvement within the organization.
• Perform other duties assigned by the direct supervisor or management.

Company Description: Established in 2014, PT Etana Biotechnologies Indonesia (Etana) is an emerging producer of high-quality, affordable and innovative biopharmaceuticals to treat a range of metabolic, autoimmune and other major life-threatening diseases, including cancer. In order to best serve Indonesian patients, Etana has established a network of strategic alliances and partnerships with international pharmaceutical producers with a strong track record in researching and developing safe and efficacious pharmaceuticals, enabling Etana to offer new treatments to the Indonesian market. At the same time, Etana is working to build Indonesia’s human resources and its own research and production capabilities by establishing environmentally-friendly, multi-purpose biopharmaceutical manufacturing and research facilities, staffed by top graduates from Indonesia’s foremost medical research and educational institutions. Job Description:

• Enforce data integrity policies and standard operating procedures (SOPs) across Technical Operation team and ensure alignment with regulatory standards such as GMP, FDA, and WHO requirements in all data practices.
• Lead routine audits and assessments to evaluate compliance with data integrity practices.
• Collaborate with IT and Quality Assurance teams to establish, implement, and maintain robust policies, validation, monitoring, training, and continuous improvement processes that ensure data integrity throughout the lifecycle of computerized systems.
• Monitor and oversee data handling, recording practices, and access permissions to ensure adherence to data integrity standards, maintain data security and traceability, and address any discrepancies in access or recording practices.
• Identify any gaps or potential risks in data handling or documentation and develop corrective actions as necessary and document audit findings and report these to management, along with recommendations for improvements.
• Collaborate with Training and Competency Development Team to plan and conduct training sessions and workshops to build awareness of data integrity principles among Technical Operation team.
• Identify opportunities to improve data governance, accuracy, and compliance, collaborate with relevant teams to implement initiatives that enhance data integrity practices, and support the development and revision of policies, procedures, and training materials to align with updated industry standards.
• Support the creation and revision of Standard Operating Procedures (SOPs), work instructions, and other quality-related documentation to ensure clarity, accuracy, and compliance with regulatory requirements.
• Participate in initiatives to continuously improve the Data Integrity by identifying inefficiencies or areas for enhancement and providing input on process improvement.
• Collaborate with cross-functional teams to implement best practices and ensure a culture of continuous improvement within the organization.
• Perform other duties assigned by the direct supervisor or management.