Quality Control Microbiologist

3 days ago

Nusajaya, Johor, Malaysia Biocon Biologics Full time 120,000 - 240,000 per year

Job Responsibilities:

  1. Execute key microbiological analyses, including Microbial Limit Test (MLT), Sterility Testing,

Contamination Check, Cell Bank Testing, Media Fill Testing, and Bacterial Endotoxin Test (BET) for

product samples.

  1. Ensure compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP),

and Good Documentation Practice (GDP) while maintaining laboratory safety standards.

  1. Investigate and report non-conformances, including Out of Specification (OOS), Out of Trend

(OOT), and deviations in product testing, implementing corrective actions.

  1. Support qualification, calibration, and maintenance of laboratory equipment, ensuring validated

and compliant testing conditions.

Product Testing & Microbial Analysis:


• Perform microbiological testing of raw materials, in-process samples, and finished products,

ensuring adherence to microbiological release specifications.


• Conduct key microbial analyses, including Microbial Limit Test (MLT), Sterility Testing, BET, and

Contamination Check for final product release.


• Subculture and preserve microbial isolates from product sample plates, ensuring traceability

and accurate microbial classification.


• Perform microbiological sampling in Production Drug Product (PDP) and Production Drug

Substance (PDS) as required.


• Ensure compliance with material and personnel movements, pest control, waste disposal, and

routine fumigation procedures.


• Conduct media fill-related activity testing, ensuring process sterility and validation of aseptic

operations.


• Ensure timely reporting and recording of microbiological test results, maintaining adherence to

GDP, batch production plan and data integrity standards.


• Investigate and report any non-conformance, Out of Specification (OOS), or deviation related to

product analysis, ensuring corrective actions are implemented.


• Review and update laboratory docs, ensuring protocols, SOPs, and EOPs are aligned with

regulatory requirements.


• Participate in CAPA execution, ensuring timely resolution of compliance-related investigations.


• Liaise with QA for deviation closure, ensuring adherence to QMS expectations and regulatory

timelines.


• Liaise with CFTs to support microbiological testing and contamination control initiatives.


• Train laboratory personnel in microbiological testing techniques, ensuring adherence to standard

methodologies and best practices.


• Conduct training sessions on laboratory equipment usage, microbiological analysis, and aseptic

control procedures.

Laboratory Operations Management:


• Perform routine verification of laboratory equipment, incl. pH meters, analytical balances, etc.


• Ensure calibration and preventive maintenance schedules are adhered to for all product testing

instruments.


• Review and approve laboratory logbooks and equipment usage records, ensuring compliance

with validation and calibration requirements.


• Act as Administrator for software-connected laboratory equipment, ensuring authorized access

control and data integrity.

Documentation & Audit Readiness:


• Maintain and update laboratory records for equipment, reagents, media, and consumables,

ensuring audit readiness.


• Prepare and review qualification and requalification protocols for microbiology laboratory

equipment, ensuring alignment with regulatory standards.


• Support internal and external audits, ensuring product testing procedures meet global regulatory

expectations.


• Track performance requalification schedules, ensuring timely execution and compliance with

planner guidelines.

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