11/21/2025 updated
100 % available
Senior CSV & Quality Assurance Consultant
Vijayawada, India
Worldwide
Masters in MicrobiologyAbout me
I am a Certified ISO 9001:2015 QMS professional with over 17 years of experience in Microbiology and sterility assurance, specializing in laboratory setup, contamination control strategies, equipment commissioning and qualification (C&Q), validation studies, and computerized system validation (CSV).
Title 21 of the Code of Federal RegulationsAudit ManagementBiotechnologyISO 9000ComplianceInformation SystemsData IntegrityEnvironmental ProtectionEnvironmental MonitoringFailure Mode Effects AnalysisInfertilityManagement SystemsMedicines and Healthcare Products Regulatory Agency (MHRA) GuidesMicrobiologyProcess Control
Computer System Validation (CSV)
Comprehensive expertise in CSV activities for GxP systems, ensuring compliance with regulatory requirements such as GxP, 21 CFR Part 11, and Annex 11
Regulatory Compliance and Audit Management
Extensive experience in regulatory inspections with agencies such as USFDA, MHRA, TGA, ANVISA, MMA, WHO, and CDSCO
Contamination Control and Sterility Assurance
Advanced knowledge in contamination control strategies, sterility testing, and environmental monitoring for pharmaceutical and biotech manufacturing
Quality Management Systems
Implementation and management of QMS including ISO 9001:2015 certification and GMP compliance
Laboratory Equipment Qualification
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for laboratory equipment
Risk Assessment and Management
Scientific Risk Assessments (SRA) for contamination control utilizing FMEA and Risk Ranking tools
Data Integrity Management
Implementation of data integrity principles and Good Documentation Practices (GDP) ensuring compliance with 21 CFR Part 11
Process Validation
Development and execution of Validation Master Plans (VMP) for new systems and manufacturing processes
Microbiology Testing Methods
Bacterial Endotoxin Testing (BET), Liquid Borne Particulate Count (LBPC), and sterility testing methodologies
Comprehensive expertise in CSV activities for GxP systems, ensuring compliance with regulatory requirements such as GxP, 21 CFR Part 11, and Annex 11
Regulatory Compliance and Audit Management
Extensive experience in regulatory inspections with agencies such as USFDA, MHRA, TGA, ANVISA, MMA, WHO, and CDSCO
Contamination Control and Sterility Assurance
Advanced knowledge in contamination control strategies, sterility testing, and environmental monitoring for pharmaceutical and biotech manufacturing
Quality Management Systems
Implementation and management of QMS including ISO 9001:2015 certification and GMP compliance
Laboratory Equipment Qualification
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for laboratory equipment
Risk Assessment and Management
Scientific Risk Assessments (SRA) for contamination control utilizing FMEA and Risk Ranking tools
Data Integrity Management
Implementation of data integrity principles and Good Documentation Practices (GDP) ensuring compliance with 21 CFR Part 11
Process Validation
Development and execution of Validation Master Plans (VMP) for new systems and manufacturing processes
Microbiology Testing Methods
Bacterial Endotoxin Testing (BET), Liquid Borne Particulate Count (LBPC), and sterility testing methodologies
Languages
EnglishNative speakerHindiNative speakerTeluguNative speaker
Project history
- Conducted internal and supplier audits across Formulations and Biotech sites, leading inspection readiness for USFDA and EMA.
- Reviewed CAPA, change controls, deviations, and batch records, and facilitated mock inspections and gap assessments.
- Supported CSV audits with focus on data integrity and audit trail review, and delivered training on GMP, DI, and regulatory preparedness.
- Led CSV activities for GxP systems per 21 CFR Part 11 and Annex 11, acting as the primary CSV contact between IT and business.
- Developed VMPs, authored and approved validation documents, and oversaw IQ, OQ, PQ, RTM, and validation reporting.
- Managed GxP system risks, supplier qualification, audit readiness, CAPA implementation, and resource estimation for validation projects.
- Drove continuous improvement in eCompliance and used JIRA/qTest for user stories, test scripts, and defect tracking.
- Utilized Asset Management and Teamcenter for system assets and change control oversight. Executed C&Q lifecycle documents (URS, FAT, SAT, IQ, OQ, PQ) in alignment with cGMP, FDA, EMA, ICH, and ISPE guidelines.
- Performed risk-based qualification, serving as SME for laboratory equipment and collaborating with cross-functional teams.
- Applied ICH Q9 to design contamination control strategies aligned with Annex 1 and ISO 14644, conducting SRAs using FMEA and assessing risks in HVAC, cleanrooms, water systems, and equipment. Designed GMP workflows to reduce contamination in aseptic processing.
Led QC Microbiology lab set-up, overseeing laboratory design, construction queries, and qualification of equipment as per industry standards using Operational Excellence principles.
Fostered collaborative team environment to uphold industry standards and regulatory compliance. Managed cross-functional teams providing technical guidance and performance oversight.
Certificates
ISO 9001-2015 Quality Management System
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