Quality Control Technician

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 28,000 - 39,000; Full time

Job summary

WUXI XDC Singapore Private Limited is seeking a Quality Control Technician to join the Microbiology team. You will perform microbiological testing of materials, support cleanroom monitoring, and help ensure product quality under regulatory and client requirements.

The role involves testing of raw materials, in-process and final release samples, maintenance of instruments, adherence to ALCOA data principles, and participation in continuous improvement within a cGMP environment in Singapore.

Qualifications

• Diploma in Life Science, Process Technology, Pharmaceutical Sciences or equivalent.
• 1-2 years of experience in the pharmaceutical or medical devices industry, with experience in a laboratory preferred.
• Familiar with PICS, ICH, Singapore HSA, FDA, EMA, NMPA, WHO technical guidelines and USP, Eur.P, ChP pharmacopoeias.
• Preferred to have knowledge on GMP manufacturing.
• Basic laboratory skills such as pipetting, glassware handling and laboratory safety.
• Attended courses associated with microbiology.
• Basic proficiencies in digital literacies such as Microsoft Word, Excel, PowerPoint.
• Ability to work independently and follow critical timelines.
• Adaptable to a changing work environment.
• Effective interpersonal skills at all internal and external levels.

Responsibilities

• To perform quality control microbiological testing of raw materials, under cGMP conditions
• To perform physiochemical testing of pharmaceutical water samples
• To perform monitoring for the facility clean utilities system e.g.
• To perform monitoring for classified cleanrooms, clean air devices and personnel.
• To perform non-routine sampling and testing for microbiological investigations.
• To perform cleaning and disinfection of laboratory instruments, controlled temperature units and equipment
• To perform, preventative maintenance of laboratory instruments/equipment
• To support aseptic process simulations
• To manage microbiological inventory required for sampling and testing
• To ensure adherence to ALCOA principles for managing laboratory data
• To adhere to site/job role training plan, and maintain individual training records
• To support continuous improvement initiatives
• To maintain laboratory housekeeping using 5S approach
• Ensure timely escalation of investigations accidents, near misses and breaches of policies
• To carry out tasks required by the reporting Manage

Skills

Microsoft Word

Microsoft Excel

PowerPoint

Education

Diploma in Life Science, Process Technology, Pharmaceutical Sciences or equivalent

Job description

The Quality Control Technician position is an integral member of the Quality Control (Microbiology) team. In this role, he/she is expected to perform the work required to ensure product quality is maintained at standard set forth by regulatory agencies, clients and corporate requirements. Some responsibilities (but not limited to) includes utilities/cleanroom monitoring, completing incoming, in-process, and final release testing of various products manufactured or received in the Microbiology Laboratory of Wuxi-XDC Singapore Private Limited.

Job Responsibilities:

• To perform quality control microbiological testing of raw materials, under cGMP conditions
• To perform physiochemical testing of pharmaceutical water samples
• To perform monitoring for the facility clean utilities system e.g.
• To perform monitoring for classified cleanrooms, clean air devices and personnel.
• To perform non-routine sampling and testing for microbiological investigations.
• To perform cleaning and disinfection of laboratory instruments, controlled temperature units and equipment
• To perform, preventative maintenance of laboratory instruments/equipment
• To support aseptic process simulations
• To manage microbiological inventory required for sampling and testing
• To ensure adherence to ALCOA principles for managing laboratory data
• To adhere to site/job role training plan, and maintain individual training records
• To support continuous improvement initiatives
• To maintain laboratory housekeeping using 5S approach
• Ensure timely escalation of investigations accidents, near misses and breaches of policies
• To carry out tasks required by the reporting Manage

Minimum Requirements:

• Diploma in Life Science, Process Technology, Pharmaceutical Sciences or equivalent.
• 1-2 years of experience in the pharmaceutical or medical devices industry, with experience on working in a laboratory environment preferred
• Familiar with PICS, ICH, Singapore HSA, FDA, EMA, NMPA, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
• Preferred to have knowledge on GMP manufacturing.
• Basic laboratory skills such as pipetting, glassware management and laboratory safety.
• Attended courses associated with microbiology
• Basic proficiencies in digital literacies such as Microsoft Word, Excel, PowerPoint
• Ability to work independently and follow critical timelines
• Ability to adapt to a changing work environment
• Effective interpersonal skills at all internal and external levels