Sr Mgr

Job Responsibilities of the Microbiology Section head:

1. Laboratory Operations:

• Planning and Execution: Plan, manage and oversee all day-to-day analytical activities within the Microbiology Laboratory. This includes scheduling, resource allocation (personnel and equipment) and ensuring efficient workflow to meet production and quality deadlines.
• Sample Control and Reporting: Allocate incoming samples to qualified microbiologists for various microbiological analysis, ensuring proper documentation and traceability. Oversee the entire batch release process from analysis through to the final reporting of microbiological test results, ensuring timely and accurate delivery of data.
• LIMS Data Management: Take responsibility for the accuracy and integrity of data within the Laboratory Information Management System (LabWare LIMS). This involves preparing, reviewing, and approving the Master data records within LIMS, as well as reviewing and approving all analytical results and batch release data entered into the system.

2. Quality, Compliance and Documentation:

• Standard Operating Procedures (SOPs): Prepare and initiate formal approval process for all departmental Standard Operating Procedures (SOPs) to ensure they are current, compliant with regulatory guidelines (e.g., GMP), and meet the CAPA expectations..
• Work Output Review: Conduct comprehensive review and approval of all analytical and documentation output generated by technicians, officers, and executives, ensuring data integrity, adherence to protocols, and regulatory compliance. Monitor the daily output of individual analysts and report to HOD..
• Equipment and Validation: Monitor and execute the scheduled activities related to the laboratory Equipment Qualification reports, Calibration Reports, and the periodic review of system Audit trails to maintain the validated state of all instruments and systems.
• Regulatory Compliance: Proactively implement Good Manufacturing Practices (GMP) and good Microbiological  practices across the entire workplace.Participate in internal and external audits. Support the HOD in preparation of compliance and implementation of appropriate CAPA. Ensure all time audit readiness within the analytical section.

3. Investigations, Deviations, and Continuous Improvement:

• Investigations: Initiate investigations and perform thorough investigation processes for critical quality events, specifically microbiological Out of Specification (OOS) and Microbial data deviations. This involves root cause analysis, risk assessment, and defining corrective actions.
• Incident and Deviation Management: Promptly initiate and conduct detailed investigations into all Laboratory Incidents and Deviations, documenting findings and ensuring timely closure in line with internal procedures and regulatory expectations.
• Change Control and CAPA: Initiate Change Control requests and CAPA related to the Microbiology laboratory and monitor the effectiveness of Corrective and Preventive Actions (CAPA) to drive continuous quality improvement.

4.  Training:

• Conduct comprehensive training programs for laboratory personnel on SOPs, new methods, equipment operation, best microbiological practices , GMP, and regulatory updates to ensure a highly skilled and competent team.