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Quality System Manager

PT Etana Biotechnologies Indonesia
PT Etana Biotechnologies Indonesia (East Jakarta, Jakarta)
DKI Jakarta, Indonesia 🇮🇩
PT Etana Biotechnologies Indonesia
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.

About this position

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

Responsibilities

• 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.

Requirements

• 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.

Benefits

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Huneety A.I Salary Estimate
9,000,000 - 26,000,000 IDR per month