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
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Kalbio Global Medika is hiring:
1. PRODUCTION (STERILE LINE) ASST. MANAGER
REQUIREMENTS
- S1 in Pharmacy/ Biotechnology/ Biology/ Bioengineering
- Min. 3-5 years experience as Production Supervisor 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
- 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. ENGINEERING SPARE PART, CALIBRATION, & PLANNED MAINTENANCE SUPERVISOR
REQUIREMENTS
- S1 in Electrical/ Mechanical/ Mechatronics Engineering with min. 2 years of experiences as a Engineering Spv.
- Able to work to timescales and under pressure
- Attention to detail to ensure high levels of quality
- Strong decision making skills
- Excellent organizational and leadership skills
- Strong communication skills, especially in English
- Strong computer skills (MS Office, AutoCad)
- Knowledge and understanding of GMP
- In Depth Knowledge related to mechanical or electrical machine control skills
- In Depth - Knowledge related to maintenance machine & calibration of instruments
- Not color blind
·JOB DESCRIPTION
- Implement an effective inventory, maintenance and calibration system in compliance with CPOB and other cGMP standards.
- Monitor of inventory, maintenance and calibration system compliance with CPOB and other cGMP standards
- Perform inventory, maintenance and calibration program of facilities in conformance to CPOB and other cGMP standards.
- Perform review and approval of main GMP documents.
3. ENGINEERING MAINTENANCE SUPERVISOR
REQUIREMENTS
- S1 in Electrical/ Mechanical/ Mechatronics Engineering with min. 2 years of experiences as a Engineering Spv
- Able to work to timescales and under pressure
- Attention to detail to ensure high levels of quality
- Strong decision making skills
- Excellent organizational and leadership skills
- Strong communication skills, especially in English
- Strong computer skills (MS Office, AutoCad)
- Knowledge and understanding of GMP
- Strong mechanical or electrical machine control skills
- Not color blind
JOB DESCRIPTION
- Implement, ensure, and monitor of maintenance system in compliance with CPOB and other cGMP standards.
- Perform maintenance program of all equipment in Production, Laboratory, R&D, QA in conformance to CPOB and other cGMP standards.
- Create and review of GMP documents.
- Ensure availability of machine spare part, by monitoring and managing the needs of spare part in collaboration with the Spare Part Supervisor.
4. ENGINEERING ELECTRICAL STAFF
REQUIREMENTS
- Minimum Diploma or Bachelor's Degree in Electrical Engineering
- Understand to read PIDs and design isometrics
- Understand PLC and pneumatic systems
- Able to operated electrical tools, such as CAD Software (2D & 3D), multitester/AVO meter, insulation test, ampere meter, grounding tester, etc
- Preferably experienced in Pharmacy or FMCG industries
- Fluent in English
- Willing to work in 3 shifts
JOB DESCRIPTION
- Perform preventive, predictive, and troubleshooting of the electrical machine/equipment.
- Able to maintain and perform machining processes, such as Filling, Blistering, Isolator, Autoclave, Mixing, etc.
- Design engineering electrical projects needed by using CAD Software.
- Manage maintenance system compliance, including SOP and other related required documents, with COP and other GMP standards.
5. ENGINEERING MECHANICAL STAFF
REQUIREMENTS
- Min. D3/ S1 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 in 3 shifts
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.
6. EQUIPMENT QUALIFICATION OFFICER
REQUIREMENTS
- S1 in Mechanical/ Electrical Engineering/ Pharmacy/ any related field
- Experienced in Qualification and Validation activities
- Experienced in Pharmacy or FMCG industries
- Have a knowledge and understanding of CPOB
- 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
- Participate in qualification and validation best practice; i.e. evaluating and establishing procedures and acceptance criteria
- Reinforce practices that make safety an ongoing consideration for all operational activities leading to a safe and clean working environment.
- Comply with and actively contribute to the continuous improvement of Kalbe and KGM Company values.
- Generate monthly report related to his field and reporting to the Supervisor.
- Support other QA activities as assigned by QA Manager.
7. TECHNICAL SERVICE & COMPLIANCE STAFF
REQUIREMENTS
- D3 Administration or any related field
- Familiar with Oracle is preferred
- Familiar with Microsoft office is a must
- Strong communication & negotiation skills including English skill.
- Having min. 1 year experience in pharmaceutical industry is preferred
JOB DESCRIPTION
- Entry production data transaction into Oracle system in a timely manner and comply to cGMP
- Generate and monitor Purchase Request, Work Request
- Maintain and control production stationary, consumables, and PPE
- Maintain and control production locker area
- Handle GMP and non-GMP document distribution in and out of Production Department
- Maintain and handle production document archival
- Perform other administration duties as assigned
8. QUALITY SYSTEM COMPLIANCE INTERN
REQUIREMENTS
- Active Student or Fresh Graduate in any related major, preferably Pharmacy or Apothecary Degree
- Good communication skills, especially in English
- Strong analytical skills and detail oriented
- Vaccinated against COVID - 19
- Willing to WFO at Cikarang for 6 months period
JOB DESCRIPTION
- Convert written material from one language to another while preserving the original meaning and format
- Maintaining personnel files, records, systems, and updated information so that information is accurate and secure
- Perform other duties as required
Forward your CV to:
Subject line: Full Name - Position
Only standout applicants will be contacted.
Sumber: Kalbio Global Medika
Baca Juga:
