Description
JOB DESCRIPTION
This role is responsible for conducting quality testing activities on pharmaceutical products in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates testing results in terms of accuracy and precision against predetermined specifications to ensure product integrity and regulatory compliance. The position identifies ongoing quality issues and takes proactive measures to prevent potential production problems, contributing to continuous quality improvement. It applies various measuring devices, testing equipment, and prescribed methodologies to accept or reject products based on defined quality criteria. The role audits and monitors testing processes and outputs against both internal and regulatory standards to uphold compliance. It tests random samples of finished goods to verify conformance with quality specifications and regulatory expectations. The position reports testing process deviations and defects in finished goods to the appropriate quality and production stakeholders. It supports the organization's commitment to delivering safe, effective, and compliant pharmaceutical products through rigorous quality testing.
Essential Functions
- Perform quality testing activities on pharmaceutical products in accordance with established specifications and regulatory requirements.
- Perform environmental monitoring (EM) of cleanrooms, controlled areas, and aseptic manufacturing environments.
- Conduct viable air, surface, personnel, and settle plate monitoring as per approved procedures.
- Observe, record, and report environmental monitoring results.
- Prepare microbiological media as per approved SOPs.
- Perform Growth Promotion Testing (GPT) of microbiological media.
- Handle, maintain, preserve, and subculture microbial cultures.
- Maintain culture inventory and ensure proper storage conditions.
- Operate autoclaves for sterilization of media, glassware, and microbiological waste.
- Verify sterilization cycles and maintain autoclave records.
- Perform Biological Indicator (BI) testing to validate sterilization effectiveness.
- Perform Specified Microorganisms testing.
- Conduct Bioburden testing for samples as per specifications.
- Perform Bacterial Endotoxin Test (BET) using approved methods.
- Conduct Sterility Testing of finished products, in-process samples, and validation samples.
- Ensure accurate documentation of all microbiological test results.
- Maintain accurate, complete, and contemporaneous records in compliance with ALCOA+ principles.
- Follow cGMP, GDP, GLP, data integrity, and laboratory safety requirements.
- Ensure adherence to SOPs, specifications, protocols, and regulatory guidelines.
- Participate in investigations related to microbiological failures, deviations, OOS, and OOT results, as assigned.
- Interpret and evaluate testing results for accuracy and precision against predetermined quality standards.
Qualifications
Education: B.Sc./M.Sc. in Microbiology, Biotechnology or a related discipline.
Experience: 3 – 7 years of experience in QC Microbiology in a sterile injectable pharmaceutical manufacturing facility.
