Nikhil Darji

Seasoned Microbiology Manager with over 18 years of experience in pharmaceutical quality control and microbiological testing. Proven expertise in managing laboratory operations remotely, ensuring strict compliance with GLP, cGMP, and GDP standards. Adept at coordinating cross-functional teams, overseeing method development and validation, and maintaining regulatory documentation. Skilled in remote monitoring of lab activities, digital reporting, and virtual audit preparedness.

Key Responsibilities & Achievements:

• Remote Oversight of Microbiology Laboratory:
  Lead and manage microbiology lab operations remotely, ensuring all functions comply with GLP, cGMP, and regulatory requirements. Utilize digital tools for planning, monitoring, and reporting.
• Daily Operations & Sample Release:
  Plan day-to-day laboratory activities, monitor progress, and ensure timely release of samples through remote coordination and review of electronic records.
• Regulatory Compliance & Documentation:
  Ensure strict adherence to GLP, GDP, and cGMP practices. Prepare, review, and revise SOPs, GTPs, validation protocols (IQ, OQ, PQ), and reports using digital platforms.
• Budgeting & Capital Planning:
  Prepare CAPEX proposals, URS documentation, and annual budgets based on remote assessments and virtual team inputs.
• Method Development & Validation:
  Oversee remote execution and documentation of method development and validation for:
• Sterility testing (closed, open, direct inoculation)
• Antibiotic microbial assay (ointment & injectable)
• Microbial Limit Test (non-sterile products)
• Bacterial Endotoxin Test (gel clot method)
• Preservative Efficacy Test (Sterile and non-sterile products)
• Administrative & Strategic Planning:
  Coordinate administrative activities, resource planning, and team scheduling remotely. Report all lab activities to the Director via digital dashboards and monthly summaries.
• Product Validation:
  Ensure microbiological validation of products for PET, MLT, Sterility, BET, and Bio-assay through remote data review and team collaboration.
• Team Leadership & Training:
  Provide virtual training, mentorship, and performance evaluations. Conduct online Q&A sessions and knowledge-sharing webinars to enhance team capabilities.
• Audit Preparedness:
  Prepare for and represent the lab during internal and international audits (MHRA, FDA, CDSCO) via remote conferencing and digital documentation.

Technical Skills & Tools:

• Remote lab management systems
• Digital documentation platforms (e.g., LIMS, ELN)
• Virtual audit tools and compliance tracking
• Microsoft Office Suite, Google Workspace

Trend analysis and reporting tools

Audit conducting at CMO and CDMO site

• To assess the CMO’s capability to manufacture pharmaceutical products in compliance with MHRA expectations, including adherence to cGMP, quality systems, and regulatory obligations.

• Managed and motivated employees to be productive and engaged in work.
• Accomplished multiple tasks within established timeframes.
• Maximized performance by monitoring daily activities and mentoring team members.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
• Laboratory Oversight & Compliance:
  Spearhead the overall management of the Microbiology Laboratory, ensuring all operations align with GLP, cGMP, GDP, and other applicable regulatory standards. Maintain a culture of compliance and continuous improvement.
• Operational Planning & Execution:
  Strategically plan and monitor daily laboratory activities, ensuring efficient workflow, timely sample release, and adherence to quality standards. Conduct regular reviews of laboratory records and reports.
• Budgeting & Capital Planning:
  Prepare and manage CAPEX proposals, URS documentation, and annual budgets based on laboratory needs and strategic goals.
• Method Development & Validation:
  Lead the development and validation of microbiological methods for new drug products, including:
• Sterility testing via closed, open, and direct inoculation methods
• Antibiotic microbial assay
• Microbial Limit Testing (MLT) for non-sterile products
• Bacterial Endotoxin Testing (BET) using gel clot method
• Documentation & SOP Management:
  Author, review, and revise SOPs, GTPs, STPs, RMTs, and validation protocols (IQ, OQ, PQ). Ensure documentation meets regulatory and internal quality standards.
• Audit Preparation & Representation:
  Represent the microbiology lab during internal, external, and international audits. Prepare detailed audit compliance reports and implement corrective actions.
• Instrument Management:
  Oversee calibration schedules, annual maintenance contracts, and qualification of new instruments. Lead installation and validation of new equipment to support lab expansion and modernization.
• Product Validation:
  Ensure microbiological validation of all products for MLT, Sterility, BET, and Bio-assay, maintaining robust quality assurance practices.
• Team Leadership & Training:
  Supervise and mentor laboratory personnel, providing technical guidance and performance evaluations. Conduct on-the-job training and organize Q&A sessions to enhance team knowledge and skills.
• Quality Systems & Investigations:
  Manage change controls, deviations, OOS/OOT investigations, and incident reporting. Ensure thorough root cause analysis and CAPA implementation.
• Cross-Functional Collaboration:
  Coordinate with engineering and other departments to resolve equipment issues and streamline lab operations. Handle material indenting to ensure uninterrupted workflow.
• Cleanroom & Aseptic Practices:
  Implement and monitor aseptic techniques in cleanroom environments. Plan and execute aseptic process simulations (media fills) and compile comprehensive reports.
• Lab Expansion Projects:
  Lead the setup of new microbiology laboratories, including layout planning, equipment procurement, and vendor technical discussions for system improvements.
• Environmental Monitoring & Trending:
  Prepare trend analysis reports for environmental and water monitoring data. Maintain archival systems for laboratory documentation.
• Audit Exposure: Local FDA, NGCMA, CDSCO, NABL

Instrumentation Expertise

• Sterility Systems: Compact Equinox, Sartorius, MDI
• Autoclaves: Fedegari, Machine Fabric, Equetron (Vertical & Horizontal)
• Particle Counters: PAMAS, HIAC ROYCO
• Air Samplers: SAS 180, Merck 100 NT
• Identification Systems: VITEK 2 (Biomerieux)
• Depyrogenation Oven: Thermo Lab
• Zone Readers: Omnicon, Digital Zone Reader
• Particle Measurement System: PMS
• Destruction Autoclave: Equetron

• Overall Management of Microbiology Laboratory and to ensure lab function is in compliance with GLP, cGMP and other regulatory requirements.
• Day to day work planning, monitoring of laboratory activities, review the records and to ensure timely released the samples.
• Ensure to strictly follow GLP, GDP & cGMP practices in Microbiology Lab.
• Preparation of Capex, its URS and annual budget as per requirements.
• New drug method development execution and method validation activity.
• Administrative activity planning in Microbiology Laboratory.
• Reporting each and every activity of microbiology lab to HOD day to day.
• Prepared the monthly report to cover each activity of microbiology laboratory.
• Preparation, review and revised the SOPs, GTPs, STPs, RMTs, all type of Validation protocols-reports and IQ, OQ, PQ protocols-reports.
• To represent Microbiology Lab during internal and external audit.
• To prepare a audit compliance report.
• Sterility test method Development and method Validation by close, open and direct inoculation method.
• Antibiotic microbial assay method Development and method Validation.
• Microbial Limit Test method Development and method Validation of Non sterile products.
• Bacterial Endotoxin Test method Development and method Validation by Gel clot method.
• Maintain Instruments calibration and Annual Maintenance Calibration activity.
• New instruments installation, calibration and validation activity.
• Ensure that each product is validated for MLT, Sterility, BET and Bio-assay.
• Supervised the personnel and provide expertise to subordinates and colleagues in the proper performance of laboratory procedures.
• Handling of change control, deviation, OOS, OOT, incident and investigation form.
• Inter department co-ordination & Eng. Department for any instrument break down.
• Preparation & execution of Hold time study protocols of sterilized articles, accessories, prepared media and working culture self life.
• Implementing & execution of aseptic practices in clean room.
• Aseptic process simulation (Media fill) planning of micro sampling and report compilation.
• Handling of Microbiologist analyst qualification program.
• Project work of new Microbiology laboratory setup.
• Discussion with vendor for technically query for improvement of the system.
• Trend analysis report of Environment and water monitoring.
• Handling of archival system of laboratory documents.
• Handling of material indent program for smooth lab work.
• On job training given to subordinate and evaluation.
• Frequently arrange question and answer session on various topics to improve the job knowledge.
• Face the internal and international regulatory audits.
• Third party testing laboratory audit, vendor audit and vendor paper audit.
• Audit Exposure:
• ANVISA Brazil, Local FDA, NGCMA and CDSCO audit.
• Instruments knowledge:
• Sterility Compact Equinox, Sartorius and MDI system
• Vertical and Horizontal Autoclave (Fedegari, Machine fabric and Equetronc)
• Liquid Born Particle Counter (PAMAS & HIAC ROYCO)
• Air Sampler (SAS 180 & Merk 100 NT)
• Particle Measurement system (PMS)
• Autoclave for destruction (Equetronc)
• VITEX 2 identification system (Biomerix)
• De-pyrogination OVEN (Thermo lab)
• Omnicon zone reader and Digital zone reader

Microbiology Laboratory Management & Compliance Microbiological Testing & Validation Expertise Instrumentation & Equipment Management Team Leadership & Quality Systems Specialized Activities Audit Experience Instrumentation Knowledge

• Ensure laboratory operations are fully compliant with GLP, cGMP, and GDP standards.
• Plan and monitor daily lab activities, review documentation, and ensure timely sample release.
• Lead method validation for new drug products, including finished and in-process samples.
• Oversee administrative planning and report all microbiology lab activities to the HOD on a daily basis.
• Prepare monthly reports summarizing all microbiological activities and performance metrics.
• Sterility Testing:
  Validate sterility test methods for injectable products using closed and open techniques.
• Microbial Limit Testing (MLT):
  Perform and validate MLT for non-sterile pharmaceutical products.
• Bacterial Endotoxin Testing (BET):
  Validate BET methods for injectable products using the gel clot technique.
• Documentation & Protocols:
  Prepare, review, and revise SOPs, GTPs, and validation protocols including IQ, OQ, PQ reports.
• Maintain calibration schedules and annual maintenance for all lab instruments.
• Lead installation, calibration, and validation of new instruments.
• Ensure product testing is validated for MLT, Sterility, and BET.
• Supervise lab personnel and provide technical guidance to ensure accurate testing procedures.
• Manage change control and deviation documentation.
• Coordinate with other departments, including Engineering, for equipment troubleshooting.
• Prepare and execute hold time studies for sterilized articles, media, and cultures.
• Implement aseptic practices in cleanroom environments.
• Plan and conduct aseptic process simulations (media fills) and compile reports.
• Manage microbiologist analyst qualification and gowning qualification programs.
• Perform trend analysis for environmental and water monitoring data.
• Maintain archival systems for laboratory documentation.
• Successfully participated in internal and international audits, including: USFDA

• Sterility Testing:
  Conduct sterility testing for injectable finished products, bulk samples, and surgical items using validated methods (closed, open, and direct inoculation) in compliance with pharmacopeial standards.
• Microbial Limit Testing (MLT):
  Perform MLT and method validation for non-sterile pharmaceutical products to ensure microbial quality and regulatory compliance.
• Bacterial Endotoxin Testing (BET):
  Execute BET for finished products and MFI (Medical Fluid Injectables) using the gel clot method, including method validation as per pharmacopeial guidelines.
• Preservative Efficacy Testing (PET):
  Conduct PET for topical, injectable, and ophthalmic products to evaluate antimicrobial effectiveness over time.
• Water System Qualification & Testing:
  Qualify and monitor water systems including Purified Water, WFI, and Soft Water, ensuring compliance with chemical and microbiological specifications.
• Liquid-Borne Particle Count Testing & Calibration:
  Perform particle count testing in injectable products using calibrated instruments such as PAMAS and HIAC ROYCO.
• Compressed Gas Monitoring:
  Monitor nitrogen gas and compressed air systems using the Pinachio Air System to ensure microbiological and particulate control.
• Aseptic Process Simulation (Media Fill):
  Plan and execute media fill activities to validate aseptic processing, including sampling and report compilation.
• Bacterial Identification:
  Identify microorganisms using the VITEK 2 system (Biomerieux) for precise and rapid microbial profiling.
• Container Closure Integrity Testing (CCIT):
  Perform microbiological CCIT to assess the integrity of packaging systems for sterile products.
• Facility & Area Qualification:
  Lead qualification activities for new cleanroom areas, ensuring environmental and operational readiness.
• Culture Standardization & Media Preparation:
  Maintain and standardize microbial cultures; prepare media and perform Growth Promotion Testing (GPT) to ensure suitability for testing.
• Personnel Gowning Qualification:
  Conduct gowning qualification for personnel entering aseptic areas to ensure compliance with cleanroom protocols.
• Biological Indicator Enumeration & Tunnel Validation:
  Validate sterilization tunnels using biological indicator vials and perform enumeration to confirm efficacy.
• Drain Point & Packaging Material Analysis:
  Perform swab analysis of drain points and packaging materials using contact plates and swabs to monitor contamination risks.
• Bio-Burden Testing:
  Conduct bio-burden testing of in-process injectable samples to assess microbial load prior to sterilization.
• Water Activity Testing:
  Measure water activity in pharmaceutical products to evaluate microbial growth potential.
• Antibiotic Microbiological Bio-Assay:
  Execute bio-assays for antibiotic potency testing in topical and injectable formulations.
• Environmental Monitoring:
  Perform comprehensive environmental monitoring using settle plates, active air sampling, and surface sampling to ensure cleanroom compliance.
• TOC & Chemical Analysis of Water:
  Conduct Total Organic Carbon (TOC) and chemical analysis of water systems to ensure purity and compliance.
• Sterility Systems: Compact Equinox, Sartorius, MDI
• Autoclaves: Fedegari, Machine Fabric (Vertical & Horizontal)
• Particle Counters: PAMAS, HIAC ROYCO
• Air Samplers: SAS 180, Merck 100 NT
• Particle Measurement System: PMS
• Destruction Autoclave: Equetronc
• Microbial Identification: VITEK 2 (Biomerieux)
• Depyrogenation Oven: Thermo Lab
• Colony Counter: Automatic (InterScience)
• Audit exposure: USFDA, MHRA, ANVISA
  

• Sterility Testing of Injectable Finished Products
• Microbial Limit Testing (MLT) of Non-Sterile Products
• Liquid-Borne Particle Count Testing
• Compressed Gas Monitoring (Nitrogen & Compressed Air)
• Culture Maintenance and Standardization
• Media Preparation and Reconciliation
• Growth Promotion Testing (GPT)
• Drain Point Swab Analysis
• Environmental Monitoring
  Settle Plates for passive air sampling
  Active Air Sampling using calibrated air samplers
  Surface Sampling via contact plates and swabs