Production Operator

Bio Tree Pharmaceutical (Int'l) Sdn Bhd; Masjid Tanah; On-site; MYR 33,000 - 50,000; Full time

Job summary

Bio Tree Pharmaceutical (Int'l) Sdn Bhd in Malaysia is seeking a production operator to assist in filling and packing according to approved BMR, uphold GMP, and maintain cleanroom practices.

You will follow SOPs, log batch records in real time, ensure line clearance, materials handling, and participate in cleaning and monitoring activities as scheduled. This role is based in Masjid Tanah, Malacca.

Responsibilities

• Adhere strictly to GMP principles, personal hygiene requirements, and cleanroom / controlled area protocols.
• Follow all approved SOPs, Work Instructions (WIs), and safety procedures without deviation
• Assist in the preparation for filling and packing of products in accordance with approved Batch Manufacturing Records (BMR).
• Perform filling and packaging process according to daily production schedule.
• Ensure correct line clearance is performed before and after each production batch.
• Complete batch records, logbooks, and production forms accurately and in real time, in compliance with data integrity principles (ALCOA+).
• Ensure all entries are legible, traceable, and free from unauthorised corrections (no use of correction fluid).
• Assist in receiving, staging, and transferring raw materials, packaging materials, and semi-finished goods within the production area.
• Ensure correct material identification, labelling, and storage conditions (temperature, humidity) are maintained.
• Maintain production areas in a clean, orderly and GMP-compliant condition at all time.
• Participate in cleaning, sanitisation, and environmental monitoring activities as scheduled
• Assist in basic cleaning and maintenance of production equipment as per cleaning validation protocols.
• Perform other production - related and ad-hoc duties as assigned by the Manager Production, Production Executive or Management.

Job description

• Adhere strictly to GMP principles, personal hygiene requirements, and cleanroom / controlled area protocols.
• Follow all approved SOPs, Work Instructions (WIs), and safety procedures without deviation
• Assist in the preparation for filling and packing of products in accordance with approved Batch Manufacturing Records (BMR).
• Perform filling and packaging process according to daily production schedule.
• Ensure correct line clearance is performed before and after each production batch.
• Complete batch records, logbooks, and production forms accurately and in real time, in compliance with data integrity principles (ALCOA+).
• Ensure all entries are legible, traceable, and free from unauthorised corrections (no use of correction fluid).
• Assist in receiving, staging, and transferring raw materials, packaging materials, and semi-finished goods within the production area.
• Ensure correct material identification, labelling, and storage conditions (temperature, humidity) are maintained.
• Maintain production areas in a clean, orderly and GMP-compliant condition at all time.
• Participate in cleaning, sanitisation, and environmental monitoring activities as scheduled
• Assist in basic cleaning and maintenance of production equipment as per cleaning validation protocols.
• Perform other production - related and ad-hoc duties as assigned by the Manager Production, Production Executive or Management.