Lowongan Kerja PT Kalbio Global Medika (a Kalbe Company)

1. Production Packaging Supervisor

Bachelor in Pharmacy, Biotechnology, Biology, Microbiology, Engineering (Mechanical, Electrical, and Industrial) or other related major

Min. 1 year experience as Packing 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

2. Engineering Project Supervisor

Bachelor in electrical/mechanical/civil engineering, or any related engineering major with minimum 2 year work experience as a project supervisor

Attention to detail to ensure high levels of quality

Strong decision making skills

Strong communication skills, especially using English

Knowledge and understanding of GMP

Strong mechanical or electrical machine control skills

In depth knowledge related to Project System, Building, Utility and Pharmaceutical Equipment

Job Description :

Plan, execute, coordinate, evaluate, and make a report for project progress and milestone periodically, including making analysis if needed.

Supervise the implementation of field assignments which must be done in accordance with the cost, quality and timeline of execution following the agreed upon work design.

Ensuring the design of utility facilities and equipment (steam, compressed air, water systems, electricity, HVAC, BMS, EMS, civil works in cleanroom areas, fire alarms, sound systems, CCTV, equipment production, etc.) in accordance with national and international standard.

Checking every equipment and supporting materials received in accordance with the design qualification or agreement. To ensure the availability of machine spare part, by monitoring and managing the need for spare parts.

Input Predictive and Preventive Maintenance (PdM & PM) and Calibration schedule related to project.

Ensuring contractors/vendors/3rd parties are working properly according to instructions and procedures, by coordinating, supervising, reviewing, and evaluating project’s work and progress.

Implement project utilities, buildings and equipment systems that comply with GMP and other cGMP standards.

3. Engineering Technician

Minimum Diploma or Bachelor’s Degree in Electro/Mechatronic Engineering or other related Engineering major

Fluent in English

Willing to work at Cikarang

Vaccinated against COVID – 19

Fresh graduates are welcome to apply

Job Description :

Follow established procedures and guidelines to install, maintain, and repair products or equipment that have been purchased by the organization’s customers

Install, service, and upgrade equipment in accordance with detailed instructions and work orders

Perform scheduled maintenance on customer installations to ensure that equipment continues to perform reliably

Maintain accurate service records so that the performance of equipment can be monitored

Develop knowledge of the organizations’ products and services by working closely with a more experienced technician or as a junior member of a service team

4. QC Inspector

Min. Diploma or Bachelor degree in Biology/Biotechnology/Pharmacy/ any related major with minimum | year experiences in quality or related field

Able to work to timescales and under pressure

Strong communication skills, especially in English

Strong computer skills (MS Office)

In-depth knowledge of GMP / COB

Analysis Method

Validation Technique

Standard Pharmaceutical Regulation

Basic Quality Assurance

Coach & Develop Others

Not color blind and visual acuity of minimum 6/12

Job Description :

Coordinate with Production team to ensure that the IPC process is in accordance with Production schedule.

Contribute to the best practice implementation in the department, by improve facilitation, and propose the improvement for working place particularly and the company generally.

Takes regulatory requirements into consideration, Safely and properly handles products.

Performing In Process Control towards finished product and stability study sample, including storing stability study sample into Stability chamber.

Participate to establish Standard Operating Procedure and Analytical Methods in QC Department.

Takes part in the qualification of laboratory equipment: draft qualification protocols, perform qualification, and draft qualification report.

5. Fill Finish Operator

Min Diploma or equivalent from Pharmacy/Biotechnology/Engineering/ any related major

Proven experience in aseptic processing and use of clean rooms, coupled with experience using automated machinery/equipment, but fresh graduated is welcomed

Excellent communication, and problem-solving skills, coupled with the ability to work collaboratively in a team-oriented environment

Knowledge and understanding of GMP and QMS

Driven to contribute to continuous improvement and ongoing learning and development

Not color blind

Able to work in shift, overtime, weekend work, and public holidays work when required

Job Description :

Complete all production tasks according to GMP, QMS and Environmental Health and Safety (EHS) requirements

Operation of aseptic filling equipment in a clean room environment by using aseptic processing techniques, gowning and the correct use of sterilized tools

Prepare product contact parts and equipment to be used in the manufacturing process, such as intermediate bottles, tubing, filters and machine parts

Assemble and operate manufacturing related equipment as required

Routine cleaning of plant, equipment and production work areas and perform environmental monitoring of clean rooms and production areas as scheduled

Completing batch record accurately and in real time

6. Warehouse Staff

Minimum High School / Vocational High School (SMA/SMK)

Minimum 2 years as Warehouse /Production Operator/administration

Good communication skills and Attitude

Attention to detail to ensure high levels of quality

Proficient computer skills, including Microsoft Office (Word and Excel)

Have a driving license of a forklift

Knowledge and understanding of Basic CGMP/ CPOB, HSSE and Halal Assurance System

Job Description :

Coordinate with warehouse helper and/or Warehouse Staff to conduct duties in carrying out daily

Receiving goods, handling and storage, handover goods.

Performing material storage in accordance with applicable storage conditions

Conducting material and finished products according to location status and physical status.

Prepare materials for production purposes in accordance with items and batches specified by the Material request form

Updating to stock card for incoming and outgoing goods

Operating forklifts and other equipment in accordance with applicable procedures.

Committed to the implementation of quality policy (Basic CGMP/CPOB), HSE and Halal Assurance System

Report an incidents or circumstances that are not in accordance with the procedure to supervisor/manager immediately.

7. IT Intern

Active Student or Fresh Graduates from Information Systems/Computer Science/ Computer Engineering/ any related major

Understanding of electrical circuits and components

Soldering skills

Pro-active and eager to learn

Experienced in Raspberry Pi or Arduino project is a plus

Experienced or have knowledge in IoT is a plus

Strong analytical skills and detailed oriented

Willing to work at Cikarang

Vaccinated against COVID – 19

Job Description :

Support development and deployment of projects in IT Application Department

Create relevant documentations including but not limited to MoM, FDS, etc

Support the IT Application Department projects as required