Quality System Manager

PT Etana Biotechnologies Indonesia

PT Etana Biotechnologies Indonesia (East Jakarta, Jakarta)

DKI Jakarta, อินโดนีเซีย

PT Etana Biotechnologies Indonesia established since 2014, engaged in manufacturing, R&D and marketing of recombinant gene-technology, monoclonal antibody (MAB’s) drugs and vaccines. PT Etana Biotechnologies Indonesia has an international scale and advanced technology cooperating with known pharmaceutical companies to develop new products and markets. Vision: To become a biotech pharmaceutical company who provide better solution for better life through the features biology product with the best quality. Mission: To be an integrated biotech company in the business of manufacturing PIC/S standard and marketing of high quality and affordable biosimilars for Indonesia and other emerging countries.

คลิกเพื่อดูงานที่คล้านกันในประเทศ อินโดนีเซีย:

ฝ่าย: การจัดการคุณภาพ

อุตสาหกรรม: เภสัชกรรม การผลิตและการผลิต

เกี่ยวกับตำแหน่งนี้

Lead the management and continuous improvements of the QMS to ensure compliance with GMP and other regulatory requirements.

หน้าที่รับผิดชอบ

• Lead the management and continous improvements of the QMS to ensure compliance with GMP and other regulatory requirements.
• Oversee the creation, revision, and management of quality documentation, including SOPs and work instructions.
• Ensure data integrity policies are establish, applied and maintained across all quality processes.
• Manage systems supporting quality operations (e.g., ERP, LIMS, eQMS), ensuring alignment with operational and regulatory needs.
• Coordinate with regulatory bodies to ensure product registration and compliance with all applicable standards.
• Develop and implement training programs to educate staff on quality standards and regulatory requirements.
• Monitor key quality metrics and ensure continuous improvement in all quality processes.

คุณสมบัติ

• Bachelor’s degree in Quality Management, Life Sciences, or related fields.
• A minimum of 10 years of experience in quality management within a regulated manufacturing environment. Pharmaceutical Industry & Sterile Manufacturing is an advantage.
• In-depth knowledge of GMP, GLP, GDP, QMS, and regulatory compliance. Other G(X)Ps is an advantage.
• Experience in Document Management, SOPs Life-Cycle, and Data Integrity Management.
• Proven leadership experience in a regulated manufacturing environment.
• Excellent communication and project management skills.

สิทธิประโยชน์

Huneety A.I Salary Estimate

9,000,000 - 26,000,000 IDR per month