Laboratory à Malaisie

To assist the Assistant Manager, Quality Control in managing and executing laboratory operations within the QC Laboratory (Biotechnology Section). This role is responsible for overseeing microbiological and biotechnological testing activities, ensuring timely completion of sampling, testing and reporting with full compliance to PIC/S cGMP, ISO 9001, ISO 17025 and SHE requirements.

The role is for a 12-month contract in Duopharma Quality Control department based in Klang. Renewal of contract is subject to the discretion of the company and personal performance.

To assist the Assistant Manager, Quality Control in managing and executing laboratory operations within the QC Laboratory (Biotechnology Section). This role is responsible for overseeing microbiological and biotechnological testing activities, ensuring timely completion of sampling, testing and reporting with full compliance to PIC/S cGMP, ISO 9001, ISO 17025 and SHE requirements.

The role is for a 12-month contract in Duopharma Quality Control department based in Klang. Renewal of contract is subject to the discretion of the company and personal performance.

• Coordinate the sampling and testing of raw materials, packaging materials, in-process (IPQC) and finished products (FPQC) in accordance with outlined timelines.
• Manage and execute environmental and utilities monitoring activities, including water systems, gases, pure steam and compressed dry air.
• Manage EM-LIMS software processes for microbiological testing, including data creation, review, approval and retrieval.
• Prepare and review microbiological trend analysis reports for utilities and environmental monitoring.
• Develop and maintain SOPs, test protocols, work instructions and related laboratory documentation.
• Coordinate and support method validation, method verification and method transfer activities.
• Review and approve microbiological and biotechnology testing reports.
• Perform sterility, BET and bioburden testing when required based on expertise and workload.
• Report and investigate non-conformance, deviations and OOS results, and ensure timely CAPA implementation.
• Participate in media fill/aseptic process simulations (APS) and visual inspections.
• Maintain overall laboratory compliance, documentation and housekeeping in accordance with PIC/S cGMP, ISO and SHE standards.
• Conduct training and competency assessment for QC staff members to ensure compliance with regulatory and internal standards.
• Support biotechnology-related study or project activities when required.
• Manage procurement of laboratory consumables, chemicals, media and related supplies.
• Perform additional duties assigned by the supervisor to support QC laboratory operations.

Qualifications

• Bachelor’s Degree in Biotechnology, Microbiology, Biochemistry or related Life Science field.

Experience

• Fresh Graduates are encouraged to apply.
• Less than 1 year working experience in Quality Control (Biotechnology/Microbiology) within the pharmaceutical industry would be an advantage.

• Strong knowledge of microbiological and biotechnology testing techniques.
• Competent in handling laboratory instruments and interpreting technical data.
• Proficient in GMP, GLP, GDP, BP/USP and ISO 17025 compliance requirements.
• Skilled in technical writing, documentation and data trend interpretation.

• Analytical mindset with strong problem-solving ability.
• Able to execute and review laboratory testing processes accurately and efficiently.
• Capable of managing documentation and compliance activities independently.

• Detail-oriented, systematic and able to work under minimum supervision.
• Strong communication and coordination skills across departments and levels.
• Demonstrates integrity, accountability and commitment to compliance.