Open to opportunities

Gangesh Chennupalli

@gangeshchennupalli

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Experienced microbiology and sterility assurance QMS professional.

India

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What I'm looking for

I seek senior roles driving microbiology, CSV/C&Q and contamination control in GMP biotech/pharma environments, with strong regulatory focus, cross-functional collaboration, and opportunities to lead audit readiness and digital transformation.

I am a certified ISO 9001:2015 QMS professional with over 17 years' experience in microbiology, sterility assurance, contamination control strategies, equipment commissioning and qualification (C&Q), validation studies, and computerized system validation (CSV). I have led laboratory setups, regulatory inspection readiness programs and CSV efforts, achieving successful outcomes with regulators including USFDA, MHRA, TGA, ANVISA, WHO and CDSCO.

I serve as a subject-matter expert across contamination control, environmental monitoring, and GMP-compliant aseptic processing, driving continuous improvement, digital transformation (LIMS, CSV) and risk-based approaches (ICH Q9, FMEA). I collaborate cross-functionally to deliver VMPs, IQ/OQ/PQ lifecycle documentation, CAPA management and audit readiness for biotech and pharmaceutical manufacturing environments.

Experience

Work history, roles, and key accomplishments

CSV, C&Q and CCS Consultant

Sugama Technologies Ltd

Nov 2023 - Dec 2024 (1 year 1 month)

Led CSV, C&Q and contamination control strategy initiatives across GxP environments, driving regulatory inspection readiness and delivering validation deliverables (IQ/OQ/PQ) to ensure compliance with 21 CFR Part 11 and Annex 11. Conducted audits, risk assessments, CAPA oversight and training to improve eCompliance and readiness for USFDA/EMA inspections.

Contaminant Control CSV Tools (JIRA qTest CAPA

Sr. Life Science Consultant

KVALITO AG

Apr 2023 - Nov 2023 (7 months)

Led QC microbiology lab setup and equipment qualification (IQ/OQ/PQ), developed SOPs and validated microbiological methods to ensure compliance with USP/EP/ISO and strengthen contamination control and sterility assurance. Performed gap analyses and sterility risk assessments to support facility readiness.

Environmental Monitoring Contaminant Control SOP Development Risk Assessment

Microbiology Team Lead

Aurobindo Pharma Limited

Mar 2017 - Apr 2023 (6 years 1 month)

Led QC microbiology teams, authored and approved GMP laboratory documentation, implemented Lean Lab initiatives and ensured regulatory inspection readiness (FDA, EMA, MHRA, WHO) while managing deviations, CAPAs and change controls to maintain product and laboratory compliance. Oversaw LIMS-driven digital projects and data integrity governance (21 CFR Part 11).

Microbiology Leadership Environmental Monitoring LIMS Data Integrity Audit Support

Assistant Manager - Microbiology

Biological E Limited

Nov 2015 - Mar 2017 (1 year 4 months)

Managed microbiological quality of utilities and aseptic processes, developed environmental monitoring programs and KPIs, supported qualification of new manufacturing blocks and led contamination control improvements contributing to successful regulatory audits (ANVISA, Thailand FDA, CDSCO, WHO).

Environmental Monitoring Utility Qualification Media Fill Oversight KPIs Contaminant Control

Executive - Microbiology

Hospira Health Care Limited

Mar 2013 - Nov 2015 (2 years 8 months)

Validated sterility and bacterial endotoxin methods, qualified instruments and facilities for greenfield projects, and executed media fill and disinfectant validation studies to meet timelines and regulatory expectations. Prepared SOPs and validation reports for sterility assurance.

Endotoxin Media Fill Studies Disinfectant Validation SOPs Greenfield Project

Executive - Microbiology

Aurobindo Pharma Limited

Mar 2008 - Nov 2012 (4 years 8 months)

Implemented contamination control and sterility assurance procedures for cleanrooms and purified water systems, performed routine microbiological testing, and supported regulatory inspections including demonstration of BET to USFDA auditors. Maintained equipment calibration and testing programs.

Contaminant Control Environmental Monitoring Equipment Calibration Regulatory