Shiue Jiun Chong

• To carry out routine microbiology laboratory operations, this includes full range of cleanroom environmental monitoring activities, and product related testing activities;
• To assist with reviewing of microbiological test data, laboratory investigations in the absence of lab manager or person in charge;
• To review product/environment microbial trends, highlight emerging trends, uncommon bacteria occurrence;
• Ensure testing elements (e.g. methods, equipment, and lab practices) are in compliance various regulatory requirements;
• Qualify and maintain respective laboratory equipment to ensure they are fit for its intended usage, with proper calibration and maintenance program established;
• Ensure continuous flow of all necessary resources (e.g. supplies, trained analysts, equipment) to enable smooth activities in the laboratory;
• Ensure accuracy, integrity, traceability and reliability of test report generated, as well as sample information submitted;
• Maintain and prepare work instructions to ensure compliance with reference standards;
• Lead laboratory equipment and test method validation / revalidation activities through establishing protocols, execution, and report documentation;
• Perform and/or support investigation and documentation of non-compliance or out-of-spec situations;
• Lead and/or review internal laboratory investigations
• Responsible for respective training activities for newcomers and qualify them on microbiological test methods;
• Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment;
• Involve in identification and evaluation of environmental aspects and impacts for Microbiology Lab
• Monitor documentation and implementation of ISO 14001:2015 for lab.
• Participate in activities related to supplier management, including supplier on-boarding process, change management reviews, supplier performance evaluations, supplier surveillance and communication.

Accomplishment:

• Involve as an Environmental Management System member that contribute to the ISO 14001:2015 certification.

• Perform daily microbiological tests according to SOP and other references.
• Perform food testing according to FDA BAM, ISO Standard method.
• Perform water testing according to APHA Method.
• Perform testing on raw material and finish product for pharmaceutical and cosmetic product according to British Pharmacopoeia and US Pharmacopoeia.
• Perform environmental monitoring (air, surface and water microbial).
• Responsible for implementation, update and development of test methods.
• Involve in method development and method verification.
• Supervise and monitor laboratory technicians in analytical tests.
• Responsible for maintenance, troubleshooting and calibration of instrument/equipment.
• Monitor documentation and implementation of MS ISO/IEC 17025.
• Involve in conducting of internal audit as technical auditor.

Accomplishment:

i. Approved signatory for microbiological Laboratory.

ii. Accreditation of Acumen Central Branch Laboratory.

• Implement Good Laboratory Practices/Quality Assurance (GLP/QA) procedures to assure that studies performed are in compliance with the OECD Principle of Good Laboratory Practices (GLP).
• Function as a Quality Assurance auditor to plan, schedule conduct, report, follow-up and close-out of inspection.
• Functions as an Assistant Archivist to assist in the establishment, management and operations of the Archives as per the Established SOPs and the Principles of GLP.