Profil Perusahaan
Kalbio Global Medika (KGM) merupakan salah satu biofarmasi pertama dan pionir di Indonesia, didirikan pada tahun 2014 dan diresmikan secara resmi pada tahun 2018 oleh Presiden Republik Indonesia, Ir. Joko Widodo.
KGM merupakan anak perusahaan PT Kalbe Farma, Tbk., penyedia layanan kesehatan terkemuka di Indonesia dan Asia Tenggara. KGM merupakan bagian dari Grup PT Kalbe-Genexine Biologics (KGbio), yang merupakan perusahaan bioteknologi tahap klinis yang fokus membawa inovasi medis biologis ke pasar di luar AS/Kanada, Eropa Barat, dan Tiongkok.
Alamat
Kawasan Industri Delta Silicon 3, Jl Soka
Blok F19 No. 002, Cicau - Cikarang Pusat,
Kab. Bekasi, Jawa Barat 17530, Indonesia
Social Media
Kalbio Global Medika saat ini sedang membuka kesempatan untuk posisi:
1. FILL FINISH ASST. MANAGER
Requirements
- Bachelor in Pharmacy/ Biotechnology/ Biology/ Bioengineering
- Min. 3-5 years experience as Packaging Supervisor in Pharmaceutical/ Biopharmaceutical/ FMCG Manufacturing, or related field
- Attention to detail to ensure high levels of quality
- Knowledge and understanding of GMP
- Fluent in English
- Willing to work at Cikarang
- Vaccinated against COVID - 19
Job Description
- Review and monitor the fill finsih 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.
- Perform end to end project related to fill finish as required
2. PRODUCTION PACKAGING SPV
Requirements
- Bachelor in Pharmacy/ Biotechnology/ Biology/ Bioengineering
- Min. 2 years experience as Packaging Supervisor in Pharmaceutical/Biopharmaceutical/ FMCG Manufacturing, or related field
- Attention to detail to ensure high levels of quality
- Knowledge and understanding of GMP
- Fluent in English
- Willing to work at Cikarang
- Vaccinated against COVID - 19
Job Description
- Organize workflow by assigning responsibilities, preparing schedules and ensuring that the required raw materials, consumables, equipment etc are available for use in a timely manner in packaging process
- Review completed batch records for completeness before transfer to Production Manager
- Review, report, and perform investigation for any deviation and/or CAPA related to packaging process
- Review validation and qualification protocols and reports and ensure correct implementation
- Ensure that packaging personel have undergone documented training for all relevant SOPs and other GMP related documents.
- Ensure the safe use of equipment and ensure regular maintenance, calibration and re-qualification as required
3. FILL FINISH SPECIALIST
Requirements
- Bachelor Degree in Pharmacy/ Biology /Microbiology/ or Biotechnology
- Able to work to timescales and under-pressure
- Strong communication skills, especially in English
- Knowledge and understanding of GMP
- Not Color Blind
- Vaccinated against COVID - 19
Job Description
- Lead the fill finish operators to perform production process according to approved BMR's and SOP's
- Perform the critical process in production process, such as formulation process
- Input the resources used in production batches into oracle system as per timeline
- Report any deviations occurring during production process, validation, or machine qualification.
- Prepare MP related documentation including but not limited to SOP's, validation and qualification protocols and reports
- Perform process validation according to the approved protocol.
- Perform machine qualification according to the approved protocol.
4. PROCESS OPERATION OFFICER
Requirements
- Bachelor Degree in Pharmacy or Apothecary
- 1-2 years experiences in Quality at Pharmaceutical Industry, Fresh Graduate are welcome
- Have a Knowledge and understanding of CPOB or GMP.
- Strong communication skills, especially in English
- Strong computer and analysis skills
- Have a knowledge and working application of FMEA and Risk Analysis
Job Description
- Update job knowledge by keeping current with regulations and accepted practices; participating in educational opportunities; reading professional publications; maintaining personal networks
- Reinforce practices that make safety an ongoing consideration for all operational activities leading to a safe and clean working environment
- Generate monthly report related to his field and reporting to the Supervisor
- Perform quality oversight activity in production area
- Review batch records and lead deviation investigation
- Develop PQR and OPV report
- Generate data trending
5. EQUIPMENT QUALIFICATION STAFF
Requirements
- Minimum Diploma or Bachelor's Degree in Mechanical/ Electrical Engineering
- Experienced in Qualification and Validation activities
- Experienced in Pharmacy or FMCG industries
- Have a knowledge and understanding of CPOB or GMP
- Strong communication skills, especially in English
Job Description
- Update job knowledge by keeping current with regulations and accepted practices; participating in educational opportunities; reading professional publications; maintaining personal networks
- Execute in qualification & validation best practices; i.e. evaluating & establishing procedures & acceptance criteria
- Reinforce practices that make safety an ongoing consideration for all operational activities leading to a safe & clean working environment
- Comply with & actively contribute to the continuous improvement of Kalbe & KGM Company values.
- Generate monthly report related to his field and reporting to the Supervisor
- Support other QA activities as assigned by QA Manager
6. UTILITY STAFF
Requirements
- Diploma or Bachelor's Degree in Mechanical/ Mechatronic Engineering or other related Engineering major with a minimum 1-year experience as a Utility Staff
- Able to use AUTOCAD and read drawings
- Preferably experienced in Pharmacy or FMCG industries
- Fluent in English
- Willing to work at Cikarang
- Vaccinated against COVID - 19
Job Description
- Manage to operate, maintain, and handle project utility system, both civil, mechanical and electrical, HVAC, water treatment, boilers and compressed air.
- Assist Supervisor in ensuring machines and equipment are optimally operated
- Assist Supervisor in ensuring machines and equipment are required to the regulation, by:
- Comply with requirements and licensing utilities
- Assist supervisor in ensuring the availability of necessary utility electrical facilities plan (Generator set, MVDB, transformator, LVMDB, Chiller, EMS and BMS, fire alarm support HSSE, sound systems support GA, CCTV support HSSE, access door support IT) by performing and assist installation, maintenance, and operation to the related parties
- To perform the availability of machine spare parts, by monitoring and managing the needs of spare parts
7. MAINTENANCE STAFF
Requirements
- Minimum Diploma or Bachelor's Degree in Mechanical Engineering
- Understand to read PIDs, design isometrics, and analyze the mechanics of material
- Familiar to operate Engineering Tools, such as CAD Software, Milling, Grinding, and Welding
- Preferably experienced in Pharmacy or FMCG industries
- Fluent in English
- Willing to work at Cikarang
- Vaccinated against COVID - 19
- Fresh graduates are welcome to apply
Job Description
- Perform preventive, predictive, and troubleshooting of the mechanical machine/equipment.
- Able to maintain and perform machining processes, such as Filling, Blistering, Autoclave, Mixing, and not limited to Milling, Grinding, and Welding.
- Design engineering mechanical projects needed by using CAD Software for 2D.
- Aware of the availability of machine spare parts, by monitoring and managing the needs of spare parts
- Manage maintenance system compliance, including SOP and other related required documents, with COP and other GMP standards.
8. INTERNSHIP PRODUCTION DS (DRUG SUBSTANCE)
Requirements
- Last Semester Student/ Fresh Graduate from Biotechnology/ Biology/ Bioprocess Engineering/ Biochemistry/ Biomedicine/ any related major
- Understand the aseptic technique/ cell culture/ liquid chromatography system/ filtration and sterilization method
- Basic knowledge and understanding of cGMP
- Good communication skills, especially in English
- Proactive and eager to learn
- Available to commit to a minimum of 6 months for the internship period
Job Description
- Support daily routine production activities
- Support drug substance batch production
- May be involved in production projects to optimize cost, improve quality or yield of product
- Perform other tasks given by direct superior, include document-related work
Send your CV to:
Subject: Name - Position
Only shortlisted candidates will be contacted & proceed further.
Sumber: Kalbio Global Medika
