AQA Microbiology Manager

Job Overview:

The Manager AQA (Microbiology) will oversee independent quality assurance oversight for the Microbiology Laboratory and Aseptic Sterile Operations. This role ensures strict compliance with global regulatory standards (USFDA, EU-GMP/Annex 1, MHRA/MOH Kenya/ANVISA) across sterile injectable lines utilizing Lyophilisation (LYO) and Sterile Dry Powder Filling. The manager acts as the primary quality gatekeeper for contamination control, environmental monitoring (EM), media fills, and data integrity.

Key Responsibilities:

1. Microbiological Quality Assurance & Oversight

• Data Review & Approval: Perform independent, system-wide review and authorization of microbiology laboratory data including Sterility testing, Bioburden, Endotoxin (BET), and Microbial Limits Testing (MLT).
• Method Validation Review: Review and approve validation protocols/reports for microbiological test methods, environmental monitoring, and rapid microbiological methods (RMM).
• Equipment & System Qualification: Quality oversight on the qualification and maintenance of critical lab equipment (e.g., autoclaves, incubators, isolators, and VHP systems).

1. Sterile Operations & Contamination Control (LYO & Dry Powder):

• Annex 1 Compliance: Drive and monitor the implementation of the Contamination Control Strategy (CCS) in alignment with revised EU GMP Annex 1 guidelines.
• Aseptic Process Simulation (APS): Review and sign off on Media Fill protocols and reports. Provide shop-floor QA oversight during active media fills and interventions.
• Lyophilisation & Powder Line Control: Oversee sterilization cycles (SIP/CIP), Glove Integrity Testing, and environmental controls specific to lyophiliser loading/unloading and dry powder filling suites.
• Cleanroom & Utilities Oversight: Review environmental monitoring (EM) trends for Grade A to D cleanrooms. Monitor trends for critical utilities including Water for Injection (WFI), Pure Steam, and Process Gases (Nitrogen, Compressed Air).

1. Quality Management Systems (QMS) & Investigations

• Deviation & OOS Management: Lead and technical review critical microbiology laboratory investigations, Out of Specification (OOS), and Out of Trend (OOT) environmental data.
• Root Cause Analysis (RCA): Deploy advanced risk assessment tools (FMEA, Fishbone) to isolate root causes of microbial excursions and execute effective CAPAs (Corrective and Preventive Actions).
• Change Control Review: Evaluate plant change controls to assess their microbiological and sterility assurance impact on manufacturing systems.

1. Regulatory Exposure & Audit Management

• Audit Readiness: Keep the microbiology laboratory and aseptic manufacturing shop floor in a continuous state of compliance for global regulatory audits (USFDA, EU-GMP, MHRA, WHO).
• Front-Facing Inspection Role: Act as the subject matter expert (SME) facing regulatory inspectors during audits for microbiology data, sterility assurance, and cleanroom qualification.
• Data Integrity Verification: Enforce ALCOA+ data integrity expectations across LIMS (Laboratory Information Management Systems) and physical paper logs.

Profile Requirements:

Education & Technical Qualifications

• Academic Degree: Master’s degree in microbiology, Biotechnology, or Life Sciences.
• Core Experience: 14 to 16 years of experience in Pharmaceutical Quality Assurance / Quality Control (Microbiology) with a minimum of 3 years in a managerial or lead AQA capacity.
• Facility Exposure: Proven experience working in a Sterile Injectable facility producing parenteral products via aseptic processing, Lyophilisation, or Dry Powder filling.