Microbiologist

Role Objective

Ensure compliance with microbiological quality standards across API / formulation manufacturing

by performing routine and specialized microbiological testing, supporting regulatory audits, and

maintaining data integrity and GMP compliance.

Key Responsibilities

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

water systems, and environments

• Conduct environmental monitoring (EM) for cleanrooms and production areas

• Handle media preparation, growth promotion tests, sterility, BET, and microbial limit tests

• Investigate OOS, OOT, and deviations related to microbiology

• Maintain microbiology lab documentation, SOPs, and logbooks as per GMP

• Support validation activities such as cleaning, sterilization, and disinfectant validation

• Participate in internal, customer, and regulatory audits (EU GMP, EDQM, MHRA, WHO)

• Ensure compliance with data integrity and regulatory guidelines

Key Skills & Competencies

• Strong knowledge of microbiology testing and GMP requirements

• Hands-on experience in API or formulation manufacturing environment

• Audit-facing experience with global regulatory agencies

• Attention to detail, documentation accuracy, and investigation skills

• Working knowledge of laboratory instruments and LIMS preferred

Key Performance Indicators (KPIs)

• Compliance with microbiological quality standards

• Timely completion of testing and reporting

• Audit observations and closure effectiveness

• Deviation and OOS handling efficiency

• Data integrity and documentation compliance