Location : Tuas Biomedical Park (company transport provided islandwide)
Job Responsibilities
- Understand and comply with GMP requirements, laboratory procedures, and controlled documentation.
- Perform microbiological testing activities, including but not limited to bioburden, endotoxin, pH, growth promotion tests, conductivity, TOC, nitrate testing, and other microbiological or chemical assays in accordance with cGMP and internal SOPs.
- Receive laboratory samples, perform testing, conduct plate reading and transfers, and report results accurately and within designated timelines.
- Execute raw material, water, gas, and environmental monitoring sampling activities according to approved sampling strategies.
- Manage EM samples by ensuring proper handling, incubation, monitoring, and documentation under controlled conditions.
- Initiate and support laboratory investigations for OOS, OOL, atypical, or deviation events, including data evaluation and documentation.
- Support inventory management for microbiology reagents, consumables, and laboratory supplies to ensure uninterrupted laboratory operations.
- Assist in raw material retention and regulatory sample management in compliance with internal and regulatory requirements.
- Ensure laboratory data integrity through complete, accurate, and timely documentation following GDP standards.
- Comply with laboratory training, preparation, documentation, housekeeping, and general laboratory maintenance requirements.
- Assist in the preparation and revision of SOPs, raw material specifications, testing protocols, final reports, investigations, and deviation documentation.
- Support validation, qualification, and change activities related to new materials, process changes, and laboratory equipment.
- Maintain laboratory notebooks, worksheets, and electronic records, and submit documentation for QA review, approval, and archival as required.
- Perform other assigned duties in support of laboratory and departmental objectives.
Requirement
- Diploma or Bachelor's degree in Microbiology, Chemistry, Biochemistry, or a related scientific discipline.
- 25 years of relevant experience in a pharmaceutical, biopharmaceutical, or GMPregulated laboratory or manufacturing environment.
- Ability to independently perform routine microbiological testing, including raw materials (RM), environmental monitoring (EM), and related assays.
- Strong understanding of GMP requirements and adherence to QC laboratory SOPs and regulatory standards.
- Experience in documenting and reviewing laboratory data in compliance with GDP and ALCOA+ dataintegrity principles.
- Capable of preparing testing protocols, reports, and basic SOPs or analytical method procedures (AMPs).
- Ability to analyze and review test results independently and perform basic laboratory or equipment troubleshooting.
- Experience in initiating and supporting laboratory investigations, deviations, or quality events.
- Able to manage workload effectively and deliver results within defined timelines.
- Capable of preparing EM trend reports and identifying opportunities to improve sampling strategies or test methods.
- Demonstrates ownership, accountability, and effective escalation of issues to supervisors when required.
- Willingness to support shift work or weekend work as operationally required.
