Lowongan Kerja Cikarang Timur Posisi Qa Staff di PT Daewoong Pharmaceutical Company Indonesia

■ Company / Team introduction with Vision

The vision of Daewoong Pharmaceuticals is to become a global healthcare group dedicated to improving quality of life.
Daewoong Pharmaceuticals has the largest number of oversea branches and subsidiaries (in total 8) among pharmaceuticals in Korea. We have been strengthening competitiveness in local markets by building diverse collaboration network with customers from research, development, manufacturing, and sales. Furthermore, we are paving the way to become a world-leading healthcare group by consistently recruiting and fostering talented people in globe and contributing to the development of local pharmaceutical industry.

PT. Daewoong Biologics Indonesia (DBI) is one of subsidiaries of Daewoong Pharmaceuticals Company Indonesia, focusing on the development of regenerative medicine in Indonesia and worldwide.
PT. DBI was established in September 2021, located in Cikarang (the total area of 10,656㎡), an industrial area in Jababeka.
PT. DBI aims to focus on its business on stem cells and cosmeceuticals. The mission of PT. DBI is to research, develop, and locally produce stem cell therapies, personalized medicines, cosmetics and more. Our vision is to become the leading stem cell and cosmetics company in Indonesia.

■ Vision

1) Possibility of expanded global business based on successful experience in Indonesia.
2) Growth Potential as Indonesia’s leading QA manager/supervisor

■ Responsibilities:

• Evaluating product stability data and other registration document data as well as managing other Pharmaceutical Industry License in accordance with the provisions of the Ministry of Health and BPOM of the Republic of Indonesia
• Follow up and manage the deviation handling, change control and corrective and preventive actions that have been approved
• Follow up and manage the handling of drug complaint, return product and drug recall
• Follow up and manage the handling of Pharmacovigilance in the company
• Conduct direct field supervision of the condition and implementation of GMP and Cosmetic GMP
• Evaluate product quality through batch record along with a test record evaluation
• Follow up and manage Quality Risk Management program in accordance with the GMP regulations
• Follow up, manage, conduct and document the calibration, qualification and validation program in the company as well as ensuring that the measurement tools are calibrated
• Making report of GMP committee meeting result
• Participate in the external audit implementation (audit to supplier, drug manufacturers and laboratories on a contract basis, Toll Out Partner)
• Participate as an auditee in the audit handling that is accepted by the company from Government, Toll In Partner and/or 3rd Party
• Monitor the materials suppliers, drug manufacturers and analysis based on contracts
• Perform implementation monitoring of the hygiene/sanitation in the company environment, especially in the critical production area also monitoring the finished product production process
• Evaluate the result of environment monitoring in the production area, QC and Warehouse, including trend data on the utilities, pest control and waste treatment in the company
• Coordinate and observe the implementation of documentation system in the company is run as the procedures
• Evaluate SOP, Work Instruction and Forms that has been made in the company as well as determine and supervise the implementation of a record keeping system of all activities

■ Qualifications:

[REQUIRED]

1. Pharmacist with minimum 3 years working experiences as QA Staff 
2. Have received training and understand the Good Manufacturing Practices (CPOB) 
3. Proficient in English (both oral & written) 

[PREFERRED]

1. Can work under pressure 
2. Good communication skills – verbal and written
3.  

■ Work Location: Cikarang