Location: Not Specified
Company: Not Specified
Designation: Head – Microbiology
Department & Sub-Area: Quality and Microbiology
Qualification:
Minimum M.Sc. in Microbiology
Experience:
Minimum 20+ years of experience in pharmaceutical microbiology, including leadership roles
Job Summary:
The Head of Microbiology is responsible for the overall management, compliance, and performance of the site’s Microbiology Laboratory. This role ensures microbiological quality of products manufactured and released to global markets by overseeing all microbiological testing, environmental monitoring, regulatory compliance, training, and laboratory operations in alignment with GMP and GLP standards.
Key Responsibilities:
Lead and guide the microbiology function to achieve all quality and microbiological targets.
Organize testing and release of raw materials, finished products, commercial/exhibit stability samples, and miscellaneous items.
Oversee microbiological testing and certification of water systems (Raw, Potable, Purified).
Manage microbial environmental monitoring of air (passive/active/compressed), surfaces, drains, and personnel in manufacturing and warehouse areas.
Supervise microbial culture handling, maintenance, and identification of isolates from various sources, ensuring systems are in place for preservation and accuracy.
Participate in OOS/OOT investigations, root cause analysis, CAPA, change controls, and ensure compliance with all quality protocols.
Support regulatory and external audits/inspections related to microbiological operations.
Prepare trend reports and annual summaries for water systems, environmental monitoring, and microbial isolates.
Ensure standardization and continuous improvement in microbiological practices and lab performance.
Maintain compliance with all cGMP, GLP, and safety regulations in microbiology labs.
Ensure product microbiological compliance through accurate and timely testing.
Train team members and act as a qualified trainer for microbiology staff.
Allocate and manage resources (personnel, equipment, training, space) for efficient lab functioning.
Conduct internal audits as per site SOPs and regulatory expectations.
Review lab documentation including logbooks, instrument calibration records, performance records, data reports, and CoAs for accuracy and completeness.
Perform all duties in line with corporate values: Pride, Accountability, Integrity, and Diligence.
Execute any additional responsibilities as delegated by the Site Quality Head.
Estimated Salary: ₹55 – ₹80 LPA (depending on regulatory exposure, site size, and expertise in sterile manufacturing or injectables)
Keywords: Head Microbiology, Pharmaceutical Quality, Environmental Monitoring, GMP Compliance, Microbial Testing, Water System Validation, QC Microbiology, CAPA, OOS/OOT, Regulatory Inspections
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