Job Summary/ Main Purpose

Machine Operator – The role holder is responsible to adhere with the cGMP principles and to maintain them in an effective manner. Follow instructions, work with other department, and help ensure that all safety regulations are followed. Overall responsible to organize the machine to ensure proper Manufacturing operations and final output. Work with maintenance department to properly utilize tools and machinery.

Key Responsibilities & Key Result Areas

• Clean all areas and equipment to be used.
• Assemble/disassemble equipment according to established procedures.
• Complete appropriate logbooks prior to requesting Quality Assurance clearance.
• Verify that all necessary materials are correct, present, released, and within the expiration period.
• Assure that all outer containers are free from dust and debris.
• Weigh materials and record all necessary dispensing information in master records.
• Calculate and prepare coating solutions according to master instructions.
• Perform Granulation, Compression/coating duties in accordance with procedures to assure that quality products that meet established specifications are generated.
• Operate and monitor machines such as RMG, FBD, Multimill, Sifter, Compression, and Coating machines as per standard operating procedures (SOPs).
• Perform machine setting, start-up, and shutdown as per the production plan.
• Ensure that equipment and process parameters are maintained within specified limits.
• Report any deviation or abnormality immediately to the supervisor.
• Weigh and document weights of processed products and rejected material.
• Complete all necessary in-process documentation.
• Label all containers appropriately.
• Label all containers appropriately including product name, Lot number, weight, number of doses.
• Assure that all scrap has been properly weighted and recorded on the batch loss tracking page.
• Perform equipment cleaning and changeover activities as per approved procedures
• Follow gowning procedure as per the SOP.

Core Competency

• In terms of competency, you are highly result oriented with strong sense of accountability & ownership.
• Good on process compliance and should be having good learners mind to understand and grasp new learnings in the workplace.
• Disciplined, Motivated, and organized
• Good communication, interpersonal, and collaboration skills.
• Ability to work under pressure & meet attendance standards.
• Must be able to manage tasks, priorities with good implementation skills.

Qualifications / Key Experiences / Functional Knowledge Requirements

• Education: Minimum Diploma or Bachelor’s
• Experience: Minimum 2 years of experience in OSD manufacturing area (granulation, compression, or coating).
• Good Command in English (Communicating, writing and speaking) is mandatory.
• Functional knowledge of pharmaceutical industry, understand the operation process
• Advance Knowledge with cGMP principles and packaging machines/process.

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