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- どれでも
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- 1
- 投稿済み
- 4時間前
- 作業モード
- 在任中
- 教育
- Degree in Microbiology / Science / related Engineering
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- 応募必須
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仕事内容
About the Company
Based in Singapore—the regional hub for Asia Pacific—this leading biopharmaceutical company has been recognized as one of the best employers in Singapore in 2020 and 2021. It has maintained a presence in Singapore for over 25 years and in the Asia Pacific region for more than 60 years.
Role Overview
Reporting to the Microbiology Laboratory Manager within the Biotechnology Facility, this role involves a variety of microbiological testing, monitoring, and coordination tasks essential for ensuring quality compliance in pharmaceutical production.
Key Responsibilities
- Conduct routine and non-routine quality checks, sampling, and testing of utility systems, including purified water, water for injection, pure steam, compressed air, and nitrogen.
- Perform environmental monitoring across plants, facilities, clean rooms, hygienic areas, and laboratories, which includes particle monitoring assessments.
- Lead and participate in personnel qualifications/re-qualifications and clean room qualifications/re-qualifications as required.
- Support plant validation activities by providing necessary testing.
- Test in-process and release samples for excipients, packaging components, semi-finished drug products, and drug substances, including sterility, bacterial endotoxin, bioburden, and microbial limits tests.
- Manage batch and routine environmental monitoring in clean rooms, production areas, and laboratories.
- Perform media receipt examinations, sterility checks, and growth promotion tests for testing media.
- Conduct initial and ongoing quality control checks on cell cultures and maintain cultures accordingly.
- Identify microbes such as bacteria, molds, and yeasts in samples from water, environment, and products.
- Review closed validation documents and standard operating procedures periodically.
- Assist in documentation support by contributing to writing and revising SOPs, protocols, test reports, and other assignments from senior microbiology staff.
- Coordinate with external vendors for calibration and maintenance of instruments.
- Manage procurement and continuous supply of laboratory consumables through quotation solicitations and vendor communications.
- Participate actively in safety, health, environment (SHE), business compliance, cGMP, and related regulatory activities.
- Supervise third-party contractors when necessary.
- Collaborate with other departments to meet training needs and provide technical support.
- Liaise with vendors and service engineers for equipment validation, calibration, and maintenance.
- Coordinate with suppliers for microbiological media and equipment provision.
- Work closely with Quality Assurance, Plant Operations, Projects, and Engineering & Maintenance departments.
- Perform any additional duties as assigned by supervisors or managers.
Qualifications and Experience
- Possess a degree in Microbiology, general Science, or a related Engineering discipline.
- Demonstrate a sound understanding of safety protocols and current Good Manufacturing Practice (cGMP) standards.
- Exhibit computer literacy for laboratory and documentation work.
- Have strong verbal and written communication skills.
Additional Information
The organization values diversity, inclusion, and the fusion of diverse ideas to accelerate innovation. It is committed to equal opportunity employment and fostering an inclusive environment. This job posting serves to build a talent pipeline for anticipated roles similar in scope and responsibility.