Duopharma Biotech Hiring! Full Time Executive, Sterile Quality Control (Microbiology) in Selangor - Ricebowl

Location: Klang, Selangor
Company: Duopharma (M) Sdn. Bhd.

We are looking for an experienced Executive to lead microbiology laboratory operations within our Quality Control Department. This role is responsible for overseeing microbiological testing, environmental and utilities monitoring, laboratory compliance, method validation, and continuous improvement initiatives to ensure compliance with PIC/S cGMP, ISO 9001, ISO 17025, and Safety, Health & Environment (SHE) requirements.

• Coordinate microbiological testing of raw materials, packaging materials, in-process samples, and finished products to ensure timely product release.

• Oversee environmental and utilities monitoring activities, including purified water systems, pure steam, compressed gases, and compressed dry air.

• Review microbiological testing results and ensure compliance with established specifications and procedures.

• Manage laboratory operations to ensure efficiency, accuracy, and compliance with quality standards.

• Coordinate microbiological method validation, verification, and method transfer activities.

• Develop, review, and maintain Standard Operating Procedures (SOPs), test methods, protocols, and laboratory documentation.

• Perform microbiological testing, including Sterility Testing, Bacterial Endotoxin Testing, and Bioburden Testing, when required.

• Ensure laboratory compliance with PIC/S cGMP, ISO 9001, ISO 17025, and SHE requirements.

• Investigate deviations, Out-of-Specification (OOS) results, and non-conformances, and implement appropriate Corrective and Preventive Actions (CAPA).

• Prepare microbiological trend analysis reports for environmental and utilities monitoring.

• Support media fill and aseptic process simulation (APS) activities.

• Participate in microbiological and biotechnology studies to support continuous quality improvement.

• Supervise, coach, and assess laboratory personnel to ensure competency and compliance with laboratory procedures.

• Manage laboratory consumables, microbiological media, chemicals, and other supplies.

• Coordinate inter-laboratory and intra-laboratory proficiency activities to maintain ISO 17025 compliance.

• Promote continuous improvement initiatives to enhance laboratory performance and operational excellence.

• Bachelor's Degree in Microbiology, Biotechnology, Biochemistry, Biological Sciences, or a related discipline.

• Minimum 5 years of experience in a pharmaceutical microbiology laboratory or related GMP-regulated environment.

• Experience in environmental monitoring, microbiological testing, and laboratory operations is essential.

• Strong knowledge of pharmaceutical microbiological testing and laboratory operations.

• Experience in Sterility Testing, Bacterial Endotoxin Testing, Bioburden Testing, and environmental monitoring.

• Good understanding of PIC/S cGMP, GLP, GDP, BP, USP, and ISO 17025 requirements.

• Experience in microbiological method validation, verification, and technical documentation.

• Ability to analyse microbiological trends, investigate quality issues, and implement CAPA effectively.

• Familiarity with Laboratory Information Management Systems (LIMS) will be an added advantage.

• Strong leadership and team development skills.

• Excellent analytical and problem-solving abilities.

• High attention to detail and commitment to quality.

• Strong communication and presentation skills.

• Self-motivated, proactive, and results-oriented.

• Ability to collaborate effectively with cross-functional teams.

• Be part of one of Malaysia's leading pharmaceutical companies.

• Lead microbiology laboratory operations in a GMP-regulated manufacturing environment.

• Gain exposure to environmental monitoring, method validation, aseptic processing, and regulatory compliance.

• Work with advanced laboratory technologies and quality systems.

• Enjoy excellent opportunities for career growth and professional development.