PT. Oneject Indonesia is a manufacturer who produces Medical Devices, especially Auto Disable Syringes.
As a pioneer of AD syringes manufacturer in Indonesia in providing safe injections, PT. Oneject Indonesia has contributed to reduce the number of standard syringes, which are produced and distributed in Indonesia. Our product is the market leader of AD syringes in Indonesia.
PT. Oneject Indonesia is growing continuously, not only in Indonesia. We have been exported our AD syringes to Asian countries and ready to enter the European market. We ensure the quality of the products at each stage of the production process starting with the selection of medical grade raw materials, the complete manufacturing process to the point of finished product. The products are monitored and controlled by our QC Department as per requirement of ISO 9001:2015 and ISO 13485:2016, in cooperation with our R&D Department, in order to continuously monitor the improvement, innovation and thereby increase our product quality.
The QA Compliance Officer position requires a minimum Bachelor's degree in a related field and at least 1 year of experience in Quality Assurance (Compliance) in the manufacturing industry. The role involves handling Change Control, CAPA implementation, documentation control, Quality Management System, Customer Complaints, Audits, and Sistem Jaminan Halal (SJH). Proficiency in Ms. Office is essential for this role.
Responsibilities
• Minimum Bachelor Degree (S1) majoring pharmacy / Pharmacist Profession (Apothecary) / Industrial Engineering / any major related
• Having minimum 1 years of working experience in Quality Assurance (Compliance) field from manufacturing Industry (from medical device manufacturer or pharmaceutical manufacturer would be an advantage)
• Experienced with Change Control, Corrective Action and Preventive Action (CAPA) implementation, documentation control, Quality Management System, Customer Complaint handling, Audit and Sistem Jaminan Halal (SJH) as well
• Excellent in Ms. Office skill
• Willing to be placed in Kawasan Industri Terpadu Indonesia Cina (KITIC) Cikarang
Requirements
• Minimum Bachelor Degree (S1) majoring pharmacy / Pharmacist Profession (Apothecary) / Industrial Engineering / any major related
• Having minimum 1 years of working experience in Quality Assurance (Compliance) field from manufacturing Industry (from medical device manufacturer or pharmaceutical manufacturer would be an advantage)
• Experienced with Change Control, Corrective Action and Preventive Action (CAPA) implementation, documentation control, Quality Management System, Customer Complaint handling, Audit and Sistem Jaminan Halal (SJH) as well
• Excellent in Ms. Office skill
• Willing to be placed in Kawasan Industri Terpadu Indonesia Cina (KITIC) Cikarang
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