Qc Microbiology Analyst

1 week ago

Singapore PSC BIOTECH PTE. LTD. Full time

**Responsibilities**:

- Perform analytical testing on raw materials, packaging components and excipients
- Carry out testing activities associated with release and stability testing of in-process control samples, intermediates, semi-finished products, and final drug substances & finished products manufactured in the plant facilities
- Carry out equipment cleaning sample testing and facility cleaning activities samples
- Ensure that tests as assigned are performed in a timely manner in accordance with standard operating procedures (SOPs) and current GMPs and GLP with necessary safety precaution
- Perform sampling on the in-coming materials as per Standard Operating Procedures including relevant documentation work required for the inspection and the sampling such as sample label generation to perform SAP transaction for incoming materials
- Perform routine/non-routine quality monitoring, sampling and testing of Utility systems inclusive of Purified water, Water for Injection, Pure steam. Compressed air and Nitrogen systems
- Perform the routine/ non-routine environmental monitoring for all required plants, facilities, clean rooms, hygienic areas and labs, inclusive of particle monitoring test
- Perform personnel qualification and re-qualification of clean room
- Perform routine and Batch related Environmental monitoring in clean rooms and other production areas
- Provide testing support to plant validation activities
- Perform in-process and release samples testing of excipients/ packaging components for the different drug products, semi-finished drug product and drug substances. i.e., Sterility test, Bacterial endotoxin test, Bioburden tests, Microbial Limits Test, etc., as appropriate
- Perform Media Receival, Sterility check and Growth Promotion Tests for media used for testing
- Perform initial Quality Control check and regular QC checks on ready-to-use cultures and maintenance of cell cultures
- Maintain complete and accurate recording of all tests performed in the relevant logbooks and worksheet
- Perform regular calibration / verification and maintenance of laboratory instruments as assigned
- Perform periodic review of laboratory standard operating procedures
- Ensure cleanliness and proper maintenance of various sampling tools and equipment
- Assist in maintaining good housekeeping of the laboratories
- Report any anomaly (e.g. Out of specifications, Out of alert and atypical events) encountered during the testing and calibration/verification of laboratory equipment
- Ensures work and behave in accordance with company SHE procedures, guidelines and expectations and publicly and privately demonstrate best SHE practice
- Any other duties as assigned by the Supervisor/ Manager.

**Requirements**:

- Diploma of related field
- Preferably with 1 to 2 years of experience in similar capacity
- Excellent team player who can maintain a positive working relationship and fosters an environment where employee engagement, empowerment, teamwork and accountability are the cultural norm
- Meticulous, willing to learn and able to work independently
- Effective communication and presentation skills
- Proficient with IT e.g. Microsoft office
- Good critical thinking and problem solving skills
- Basic cGMP knowledge and professional behavior is a must

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