QC Section Head
work Deskripsi Pekerjaan
Qualifications :
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Bachelor Degree from majoring in Pharmacy / Chemical / Industrial Engineering
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Having minimum 3 years of working experience in QC area from medical device manufacturer would be an advantage
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Have good knowledge regarding of ISO 13485, cGMP, and quality control requirements applicable to medical devices, experienced in Lead and supervise all Quality Control activities covering Incoming Quality Control (IQC), In-Process Control (IPC), and Finished Goods (FG) testing and release, Ensure all incoming materials, components, and packaging materials are inspected and released in accordance with approved specifications and sampling plans, Ensure all QC activities comply with ISO 13485, cGMP, internal SOPs, and applicable regulatory requirements, Lead and participate in investigations related to OOS, OOT, nonconformities, deviations, and customer complaints related to product quality
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Good communication in English both written or verbal
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Strong analytical, problem solving skills and attention to detail
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Willing to be placed in KITIC Cikarang
Tentang PT Oneject Indonesia
PT. Oneject Indonesia is a Medical Devices manufacturer produces 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 with 90% market share.
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.
PT. Oneject Indonesia is a Medical Devices manufacturer produces 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 with 90% market share.
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.
Industri: Pharmaceuticals, Biotechnology & Medical Devices
school Kualifikasi
- Bachelor Degree from majoring in Pharmacy / Chemical / Industrial Engineering
- Having minimum 3 years of working experience in QC area from medical device manufacturer would be an advantage
- Good communication in English both written or verbal
- Strong analytical, problem solving skills and attention to detail
- Willing to be placed in KITIC Cikarang
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