Pharmaceutical Company jobs in Kulim

JOB DESCRIPTION – MICROBIOLOGIST

Position: Microbiologist
Company: Brosmed Medical (Malaysia) Sdn. Bhd.
Industry: Medical Device Manufacturing
Department: Quality Control / Microbiology Laboratory

Job Summary

The Microbiologist is responsible for performing microbiological testing, environmental monitoring, and laboratory activities to ensure that raw materials, in-process products, finished products, water systems, and the manufacturing environment comply with established quality, safety, GMP, and ISO 13485 requirements.

The position also supports cleanroom monitoring, investigation of microbiological deviations, maintenance of laboratory records, and implementation of corrective and preventive actions.

Key Responsibilities

• Conduct microbiological testing on raw materials, in-process products, finished products, water samples, and environmental samples.
• Perform routine environmental monitoring of cleanrooms and controlled manufacturing areas.
• Support the cleanroom hygiene and contamination control programme.
• Prepare culture media, reagents, solutions, and other materials required for microbiological testing.
• Perform microbiological testing according to approved Standard Operating Procedures (SOPs) and testing methods.
• Record, review, interpret, and report microbiological test results accurately and promptly.
• Maintain complete and accurate laboratory records, worksheets, logbooks, test reports, and related documentation.
• Investigate microbiological deviations, abnormal results, Out-of-Specification (OOS) results, and environmental monitoring excursions.
• Assist in identifying root causes and implementing appropriate Corrective and Preventive Actions (CAPA).
• Monitor microbial trends and identify potential contamination risks within production and laboratory areas.
• Ensure laboratory equipment and instruments are properly maintained, calibrated, cleaned, and used according to established procedures.
• Ensure microbiological laboratory practices comply with GMP, ISO 13485, company SOPs, and applicable regulatory requirements.
• Support internal and external audits related to microbiological testing and contamination control.
• Assist in reviewing and updating microbiology-related SOPs, work instructions, specifications, and laboratory procedures.
• Maintain good laboratory housekeeping and ensure compliance with laboratory safety requirements.
• Work closely with the Quality Assurance, Quality Control, Production, Engineering, and other relevant departments on microbiological and contamination-control matters.
• Perform any other duties related to microbiology and quality control as assigned by the superior or management.

Job Requirements

• Diploma or Bachelor’s Degree in Microbiology, Biotechnology, Biomedical Science, Biological Science, or a related discipline.
• Relevant laboratory experience in the medical device, pharmaceutical, biotechnology, or manufacturing industry is preferred.
• Fresh graduates with suitable academic qualifications are encouraged to apply.
• Knowledge of microbiological testing methods, aseptic techniques, environmental monitoring, and contamination control.
• Familiarity with GMP and ISO 13485 requirements will be an advantage.
• Good understanding of laboratory documentation and Good Documentation Practices.
• Proficient in Microsoft Office, particularly Word and Excel.
• Good analytical, troubleshooting, and problem-solving skills.
• Good communication skills in English and Bahasa Malaysia; ability to communicate in Mandarin will be an added advantage.
• Responsible, detail-oriented, disciplined, and able to work independently.
• Able to work effectively as part of a team and collaborate with different department.

Pay: RM3,000.00 - RM4,000.00 per month

Work Location: In person