Job Description

About the job

Microbiology Lead

Company: Pharco Corporation

Job Title: Microbiology Lead

Department: Quality Control

Location: Alexandria, Egypt

Reporting To: QC Manager

Job Purpose

The Microbiology Lead is responsible for leading and overseeing the microbiology laboratory activities within the Quality Control function, ensuring that all microbiological testing, environmental monitoring, personnel practices, documentation, and laboratory operations are performed accurately and in full compliance with GMP, GLP, pharmacopeial requirements, and applicable regulatory standards.

The role provides technical leadership to the microbiology team, ensures timely and reliable testing results, supports investigations and continuous improvement, and maintains the microbiology laboratory in a state of inspection readiness.

Key Responsibilities

1. Microbiology Laboratory Operations

• Lead and supervise daily activities of the QC Microbiology laboratory.

• Ensure timely execution and review of microbiological testing for raw materials, finished products, water, in-process samples, and other required samples.

• Oversee environmental monitoring activities, including viable and non-viable monitoring where applicable.

• Ensure proper execution of microbial limit tests, sterility testing, bacterial endotoxin testing, growth promotion tests, and other applicable microbiological analyses.

• Ensure appropriate handling, identification, storage, and disposal of microbiological samples and cultures.

• Monitor laboratory workload and allocate tasks effectively among microbiology team members.

2. GMP & Compliance

• Ensure microbiology activities comply with GMP, GLP, SOPs, pharmacopeial standards, and approved specifications.

• Ensure laboratory documentation is complete, accurate, traceable, and compliant with data integrity requirements.

• Maintain microbiology laboratory readiness for internal, customer, and regulatory inspections.

• Participate in the preparation and implementation of SOPs, work instructions, protocols, and microbiological procedures.

• Ensure proper management of laboratory deviations, OOS/OOT results, incidents, CAPAs, and change controls.

3. Environmental Monitoring & Utilities

• Supervise environmental monitoring programs for classified and controlled areas.

• Review environmental monitoring trends and identify potential adverse trends or contamination risks.

• Oversee microbiological testing of pharmaceutical water systems and other relevant utilities.

• Participate in contamination control activities and investigations related to microbiological excursions.

• Support the implementation and continuous improvement of the site’s Contamination Control Strategy (CCS).

4. Method Validation & Qualification

• Lead or support microbiological method validation, verification, suitability, and transfer activities.

• Review and approve microbiological protocols, reports, and associated technical documentation.

• Ensure microbiological test methods remain scientifically sound and compliant with current pharmacopeial requirements.

• Support qualification and validation activities related to microbiology laboratory equipment and processes.

5. Investigations & Problem Solving

• Lead microbiological investigations related to OOS, OOT, environmental monitoring excursions, contamination events, and other laboratory deviations.

• Perform root cause analysis using appropriate investigation tools.

• Define and follow up on effective CAPA plans.

• Provide technical microbiology support to QA, Production, Engineering, and other relevant departments.

6. Team Leadership & Development

• Lead, supervise, and develop microbiology analysts and laboratory personnel.

• Assign responsibilities and monitor individual and team performance.

• Provide technical guidance, coaching, and on-the-job training.

• Identify training needs and support the development of the microbiology team’s technical competencies.

• Evaluate team performance and provide constructive feedback.

7. Documentation & Reporting

• Review laboratory records, worksheets, analytical results, logbooks, and microbiological reports.

• Ensure accurate and timely reporting of microbiology laboratory results.

• Prepare periodic reports and trend analyses for microbiological monitoring activities.

• Maintain appropriate laboratory records in accordance with GMP and data integrity requirements.

8. Continuous Improvement

• Identify opportunities to improve microbiology laboratory efficiency, reliability, and compliance.

• Participate in quality improvement and risk management initiatives.

• Keep updated with changes in pharmacopeial requirements, GMP expectations, and microbiological testing practices.

• Support implementation of new technologies, methods, and laboratory practices where applicable.

Job Requirements

• Bachelor’s degree in pharmacy, Science – Microbiology.

• Minimum 10 years of relevant experience in pharmaceutical microbiology, preferably within a QC laboratory environment.

• Previous experience in a lead/senior microbiology position is highly preferred.

• Strong practical knowledge of pharmaceutical microbiological testing and environmental monitoring.

• Good knowledge of GMP, GLP, data integrity, pharmacopeial requirements, and microbiological laboratory practices.

• Hands-on experience with relevant microbiological techniques and laboratory equipment.

• Strong knowledge of OOS/OOT investigations, deviations, CAPA, change control, and risk assessment.

• Good analytical, problem-solving, and decision-making skills.

• Strong leadership, communication, and team-management abilities.

• Good command of English language, particularly technical and pharmaceutical terminology.

• Proficiency in Microsoft Office applications.