QC Microbiology - Sr. Executive

Job Title: Quality Control (QC) Microbiology - Sr. Executive

Key Responsibilities

Microbiological Testing & Analysis

• Conduct sterility and BET sample analysis, aseptic area monitoring (VPC and NVPC), media preparation, culture handling, MLT, and water analysis.
• Ensure all microbiological testing is performed in compliance with quality specifications and regulatory requirements.
• Perform routine and non-routine microbiological testing and ensure timely submission of test results.

QMS & Documentation Management

• Manage and maintain accurate and detailed documentation for all microbiological testing activities, including test reports, certificates of analysis, and batch records.
• Ensure proper handling of QMS documentation as per GMP standards, supporting regulatory and internal audits.
• Prepare and review documentation for compliance with internal procedures and external regulatory guidelines.

Calibration, Qualification & Validation

• Perform calibration, qualification, and validation of microbiological equipment and laboratory instruments.
• Ensure microbiological instruments meet the required qualification standards and are in optimal working condition.
• Troubleshoot technical issues related to microbiological testing and laboratory equipment.

Compliance & Safety

• Adhere to cGMP, GLP, and safety guidelines during microbiological testing processes.
• Ensure aseptic techniques and environmental monitoring practices are followed to maintain product quality and laboratory safety.
• Monitor laboratory safety standards and ensure adherence to company protocols and industry regulations.

Continuous Improvement & Technical Support

• Participate in investigations and root cause analysis for deviations and non-conformances in microbiological testing.
• Support continuous improvement efforts in laboratory processes, testing methodologies, and equipment handling.
• Provide technical guidance and troubleshooting support to junior staff in microbiological testing.

Key Requirements

• Experience: 7+ years in Quality Control within the pharmaceutical industry, specializing in microbiological testing.
• Technical Expertise: Proficient in sterility and BET sample analysis, aseptic area monitoring, media preparation, culture handling, MLT, and water analysis.
• QMS Familiarity: Experience handling and managing QMS documentation and ensuring compliance with GMP standards.
• Calibration & Validation: Hands-on experience in the calibration, qualification, and validation of microbiological laboratory equipment.
• Compliance Knowledge: Strong understanding of cGMP, GLP, and regulatory requirements for microbiological testing.
• Attention to Detail: Excellent analytical skills and attention to detail in testing, documentation, and troubleshooting.
• Communication: Strong verbal and written communication skills, with the ability to work effectively in a team environment.