Team Member QC Microbiology

Role & responsibilities

Job Summary
We are seeking an individual for the Quality Control Microbiology team, responsible for review and approval of microbiology analytical data/record, review of EM and water trend, monitoring of aseptic process simulation. Review and approval of Analytical method validation related to Microbiological test. This role includes the participation into investigation related to Microbiology
Roles & Responsibilities
Responsible for Review and release of Microbiological Tests (Environmental Monitoring, Water Testing, Microbial Limit Test, Sterility Test and Bacterial Endotoxins Test).

Responsible for review and Approval of Microbiological testing data/ Master data in LIMS.

Handling of QMS elements like change control, Incident, OOS, OOT and CAPA related to Microbiology.

Responsible to carry out the investigations related to Microbiology and timely closure of the same within the defined timeline.

Review and approval of SOPs, protocols and reports related to Microbiology.

Ensuring the compliance of Audit observations related to Microbiology.

To review trends as applicable and to recommend any changes for the better control of the system.

To review and approve STPs, Specifications, preparation of record of analysis and analytical test report.

To ensure cGLP activity in lab and compliance in Microbiology laboratory.

Responsible for the Monthly audit trail review of Instrument /Equipments related to microbiology.

Responsible for the review and approval of Analytical method validation with respect to Microbiology.

Monitoring of Media Fill/ Process Simulation and review of media fill protocols and reports.

Educational qualification: A Master degree in Microbiology, or a related field.

Minimum work experience: 5 to 8 years of experience in Pharmaceutical Microbiology / Quality assurance or a similar role

Skills & attributes:

Technical Skills
• Knowledge of microbiology and aseptic practices and Aseptic Process simulation activities and disinfectant validation and handling of Microbiological Cultures.
• Skilled in review of Microbiological data, EM, water and compressed air trends.
• Review of EM and water trends, trends, Handling of Microbiological Culture.
Behavioural Skills
• Attention to detail in performing line clearance, verification, and record reviews.
• Skilled in time management and coordination for sampling, testing, and execution of batch manufacturing and packing activities.
• Communicates effectively with team members and stakeholders regarding batch-related activities and compliance.
• Applies problem-solving skills in addressing issues related to line clearance, sampling, and record certification.
• Demonstrates a focus on maintaining high-quality standards and adhering to regulatory compliances in manufacturing processes.