Senior Technician, Microbiologist (Pharmaceutical)

Duopharma Biotech; Klang City; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Klang is seeking a Quality Control associate for a 7-month contract. Responsibilities include managing laboratory operations, conducting microbiological testing, and ensuring compliance with stringent health and safety guidelines. Candidates should hold a degree in Microbiology or Biotechnology, with fresh graduates encouraged to apply. Skills in analytical methods, problem-solving, and communication are essential. This position offers a unique opportunity to work in a dynamic quality control environment.

Qualifications

• Fresh graduates are welcome to apply.
• 1 year of working experience in a related industry is an advantage.
• Must be well-versed in documentation.

Responsibilities

• Assist in managing laboratory operations for pharmaceutical products.
• Conduct microbiological analysis of water samples.
• Prepare quarterly trending reports for monitoring.
• Ensure compliance with cGMP and ISO requirements.
• Manage sample arrangement at the QC Retention Area.

Skills

Analytical skills

Problem-solving skills

Communication skills

Knowledge of cGMP

Knowledge of GLP

People management skills

Education

Degree in Microbiology, Biotechnology, or equivalent

Job description

The role is for a 7-month contract in Duopharma Quality Control department based in Klang.

Assist the Assistant Manager/ Senior Executive, Quality Control to manage and execute laboratory operations for pharmaceutical products in the Quality Control Laboratory.

Conduct environmental monitoring/ utilities monitoring as per the program schedule.

Monitoring of instrument verification to comply with PIC/S cGMP and ISO requirements.

Responsibilities

Perform water sampling for all types of water located in K1, K2, and K3 from all required sampling points as per approved procedures.

Perform monitoring of pure steam, compressed gases, and compressed dry air as per the schedule.

Conduct microbiological analysis of water samples such as total plate count, microbial limit test, and bacterial endotoxin test, and record the results accordingly.

Responsible for data entry and reporting of all environmental monitoring and utilities monitoring activities in LIMS in a timely manner.

Prepare quarterly trending reports for environmental monitoring and utilities monitoring.

Report any non-conformance, out-of-specification results, or deviations occurring due to environmental and utilities monitoring, or analysis.

Assist in the preparation of protocols, study reports, Standard Operating Procedure, Work Instructions, CAPA implementation, and other documents in accordance with current requirements and relevant references.

Assist in media preparation and growth promotion testing for microbiological media used in environmental and utilities monitoring.

Perform identification of microbial isolates obtained from environmental and water monitoring.

Ensure strict adherence to laboratory compliance with PIC/s cGMP (current Good Manufacturing Practice), ISO (9001, 13485 and 17025) and SHE (Safety, Health, & Environment) requirements.

Conduct Heparin Testing for Finished Goods and Stability Study samples in compliance with GLP, Halal requirements, and specified guidelines.

Perform Microbial Contamination Testing for Finished Goods, Raw Materials and stability study samples in accordance with test methods and specifications. according to approved test methods and regulatory guidelines.

Perform Bioburden Testing, Volume Checks, and Weight Checks on in-process injectable products for the Sterile Plant, following the approved test methods and specifications.

Perform blood centrifugation for plasma collection as per the scheduled testing plan in the Heparin Assay.

Ensure Sertu cleaning is performed for glassware used in Heparin Assay.

Conduct pH measurement and particle count analysis for Unihepa Injection.

Conduct Bioburden Testing for cleaning validation samples to ensure compliance with established standards.

Conduct support microbiological testing, such as media preparation, growth promotion tests, container closure integrity tests, and microbial identification, as per approved procedure.

Manage sample arrangement at the QC Retention Area to ensure proper storage and traceability.

Qualifications

Must possess at least Degree in Microbiology, Biotechnology, or equivalent.

Fresh graduates are welcome to apply. Having 1 year of working experience in a related industry will be an added advantage.

Knowledge of cGMP, GLP, and laboratory instruments are essential.

Analytical skills, problem‑solving skills, people management skills and communication skills are required and must be well‑versed in documentation.