Production Sterile Assistant Manager
Kalbio Global Medika
- Penuh waktu
- On-site • Cikarang
- Negotiable
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Deskripsi Pekerjaan
Job Description:
- Review and monitor the fill finish and related process SOP’s for technical content and ensure approved SOP’s are available and implemented.
- Monitor and maintain production budget scope, not limited to implement cost-saving strategies and techniques
- Review the realization of routine process on production to achieve target implementation.
- Develop technical expertise in area of responsibility and provide technical instruction/training on current and new/improved processes to fill finish personnel.
- Lead, mentor, evaluate, and develop fill finish personnel team.
- Responsible for developing department goals, objectives, and systems.
Kualifikasi
Requirements:
- Bachelor in Pharmacy/ Biotechnology/ Biology/ Bioengineering
- Min. 3-5 years experience as Production Supervisor (Sterile line) in Pharmaceutical/Biopharmaceutical
- Attention to detail to ensure high levels of quality
- Knowledge and understanding of GMP
- Fluent in English
- Willing to work at Cikarang
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Kalbio Global Medika is a subsidiary of PT. Kalbe Farma, TBK which is engaged in the manufacture of pharmaceutical products. PT Kalbio Global Medika (KGM) is a contract GMP biomanufacturing company specializing in the use of mammalian cells. KGM is PIC/s compliant, obtaining GMP accreditation from the Indonesian Regulatory Agency (BPOM) in 2017. The facility has state of the art equipment to perform manufacturing for drug substance and drug product, through to packaging and final release. The drug substance is manufactured using roller bottles or bioreactors, currently, the bioreactor capacity is 40L scale but in the future, we will have up to 1000L capacity. For finished products, KGM can fill into syringes, cartridges and vials. KGM is currently working with international clients, based in Asia and South America.
