Microbiology Analyst

4 days ago

Singapore MSD Full time

**THE OPPORTUNITY**
- ** Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide**:

- ** Based in Singapore**, the regional hub for **Asia Pacific (AP) **and **top-ranked biopharmaceutical company on the Straits Times **and** Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).**:

- Join the** premier biopharmaceutical company** that has been **in Singapore for more than 25 years and in AP for over 60 years.**

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

As part of the QC Microbiology team in Singapore, Microbiologists and Analysts also qualify competent employees to perform precise sampling to monitor the quality of the facility's critical systems, such as water systems and cleanrooms to meet pharmaceutical grade waters and classifications for its intended manufacturing use. The data generated from the laboratory is analyzed by the Microbiology department, and valuable in supporting the Manufacturing Division for decision making, and as sharing for other network sites to leverage on. This position reports to the Manager in the Microbiology Laboratory.

**What will you do**
- 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.

**What you must have**
- 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
- Fresh graduates with rele

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