PT Etana Biotechnologies Indonesia

PT Etana Biotechnologies Indonesia adalah perusahaan biofarmasi yang berfokus pada produksi, penelitian, dan pengembangan obat berbasis bioteknologi. Perusahaan ini berdiri pada tahun 2014 dan berkembang sebagai produsen biofarmasi yang menyediakan produk inovatif dan terjangkau untuk menangani penyakit metabolik, autoimun, hingga penyakit berat lainnya seperti kanker.

Perusahaan ini mengembangkan berbagai produk berbasis rekayasa genetika, antibodi monoklonal (MABs), serta vaksin. Dengan teknologi berskala internasional, Etana bekerja sama dengan berbagai perusahaan farmasi global untuk mengembangkan produk baru dan memperluas pasar. Fokus perusahaan tidak hanya pada produksi, tetapi juga pada riset dan pengembangan (R&D) untuk menghadirkan solusi kesehatan modern.

Dalam operasionalnya, PT Etana Biotechnologies Indonesia menerapkan standar cGMP yang telah memenuhi persyaratan PIC/S, sehingga produk yang dihasilkan dapat dipasarkan untuk kebutuhan domestik maupun internasional. Perusahaan juga mengedepankan budaya kerja yang berorientasi pada kualitas dan pengembangan SDM, dengan melibatkan tenaga profesional dari berbagai disiplin ilmu seperti farmasi, teknik kimia, dan kedokteran.

Perusahaan ini juga mendapatkan pengakuan strategis sebagai Laboratorium Pusat Unggulan (Center of Excellence) untuk pengembangan vaksin dan bioteknologi, dengan mandat memperkuat riset, meningkatkan kapasitas SDM, dan memperluas kolaborasi internasional. Dengan visi menjadi perusahaan biofarmasi yang menyediakan solusi kesehatan berkualitas tinggi, Etana terus memperkuat perannya dalam ekosistem kesehatan nasional dan global.

Lowongan Kerja PT Etana Biotechnologies Indonesia

QA Onsite Specialist

Job Summary:

• Conduct inspections, evaluations, and assessments of events that occur during, before, or after the process in relation to GMP compliance.
• Assess the impact on product quality, regulatory compliance, patient safety, and the fulfilment of the GMP system.
• Conduct an assessment of the investigation performed and ensure that the investigation has identified the root cause in accordance with the events and deviations that occurred.
• Ensure that CAPA actions are appropriate and aligned with the deviations that occurred.
• Coordinate the completion of deviation reports with the relevant departments and ensure the completeness of the deviation reports.
• Provide explanations and conclusions in the deviation report aid close the deviation report.
• Conduct trend of events and deviations occurring within a specific period.
• Perform other tasks given by direct superior or management.
• Work in accordance with HSE rules and regulations that apply in the company.

Requirements:

• Must have min. Bachelor Degree in Pharmacy, Biology and Apothecary.
• Have min. 2 years of working experience in related work.
• Have good research skills, analytical thinking, and problem-solving skills.
• Able to communicate well and establish interpersonal relationships.
• Able to work independently (self-motivated), take initiative, and within a complex team environment.
• Have a knowledge about GMP, Quality Management System, Deviation Handling, SJP.
• Fluent in English (Written and Verbal).
• Willing to work in East Jakarta.

 MST / Manufacturing, Science, and Technology Process Specialist

Job Summary:

• Conducted a literature study related to the process of making drug products developed by the company.
• Detailed and explain the drug substance production process developed by the company.
• Prepare and produce technology transfer and/or internal development documents related to the development of drug products in the company.
• Analyze and create documents related to all forms of gaps (gap analysis) related to the development and manufacturing process of drug products.
• Conduct and follow up the implementation of all product quality risk management documentation related to the development of drug products.
• Documenting all matters relating to quality and supporting activities related to drug substance development. Prepare batch records for the processing of drug products and other supporting documents for the development of non-GMP and GMP drug products.
• Assisting in preparing process validation document for drug substance development.
• Prepare all the things needed before executing trials such as material, equipment, and personnel.
• Perform other tasks given by direct superior or management.

Requirements:

• Have a min. of Bachelor Degree in Biology, Biotechnology, Chemical engineering, Pharmacy, Medical, Microbiology, and Chemistry.
• Have a min. of 2 years of working experience in related work or pharmaceutical industry.
• Fresh graduates are welcome to apply.
• Able to learn and adapt fast to Laboratory scale biological product manufacturing, Principle of GMP, Principle of Quality by Design, Principle of Biosafety, Principle of Sterile Production.
• Fluent in English (Written & Spoken).
• Have a strong sense of integrity and ethics.
• Willing to learn and work in a fast-paced environment.
• Willing to be stationed in East-Jakarta.

QA Compliance Associate Specialist

Job Summary:

• Ensure the implementation of evaluation of suppliers and third parties are on schedule and documented well.
• Oversee change control management to ensure changes are documented and controlled.
• Perform Change Control trend.
• Documented Change Control process from submission, evaluation, to approval in the applicable system.
• Perform other tasks given by direct superior or management.
• Work in accordance with HSE rules and regulations that apply in the company. (Tercatat dua kali di foto).

Requirements:

• Have min. Bachelor Degree in Pharmacy, Biology, or Chemistry.
• Have min 1 year of experience in the Pharmaceutical Industry (fresh graduate are welcome).
• Excellent prioritization, time management, and critical thinking skills.
• Possess a solid understanding of GxP principles, Quality Auditing, Quality Risk Management, CAPA handling, and Halal Product Assurance Systems.
• Able to work independently (self-motivated) and within a complex team environment.
• Fluent in English (both written and spoken).
• Willing to be stationed in East-Jakarta.
• Willing to work with limited resources in a Start-Up Environment.
• Willing to work with overtime if needed.

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