Manisha

QA & Microbiology Professional with 3 years of experience in Medical Devices, Pharmaceutical and Food Testing Laboratories. Experienced in Sterility Testing, bio burden Testing, Environmental Monitoring, Sterilization Validation, CAPA, Deviation Investigation, Root Cause Analysis (RCA), SOP Preparation, QMS Documentation and Regulatory Compliance. Hands-on experience in ISO 13485:2016 Quality Management System, microbiological testing, validation activities, audit support, documentation control and contamination control practices.

Familiar with ISO 14644 Cleanroom Standards, ISO 14971 Risk Management, ISO 11135 (EO Sterilization), GDP, GMP, GLP, US FDA and EU MDR regulatory requirements. Strong analytical, Documentation and problem-solving skills with the ability to work effectively in cross-functional teams while maintaining product quality and regulatory compliance.

Microbiologist-QA - Newtech Medical Devices Pvt. Ltd. - Faridabad

(2024-12 - 2026-06)

• Performed Sterility Testing, Bio burden Testing and Environmental monitoring.
• Conducted Microbial Identification and pathogen testing.
• Supported implementation and maintenance of ISO 13485:2016 Quality Management System (QMS).
• Prepared, reviewed, and controlled SOPs, validation protocols, reports, and quality documentation.
• Performed CAPA, deviation investigations, and Root Cause Analysis (RCA) to support quality improvements.
• Reviewed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) ensuring compliance with GMP requirements.
• Supported Sterilization Validation, Functional Validation, and Stability Studies.
• Assisted documentation activities related to EO Sterilization and maintained awareness of Gamma Sterilization requirements.
• Maintained audit-ready documentation for internal and external audits.
• Ensured documentation compliance with GDP, GMP, and Quality System requirements.
• Collaborated with cross-functional teams to support product quality and continuous improvement initiatives.

Junior Microbiologist - Micates Research and Analysis - Faridabad

(2023-05 - 2024-12)

Food, Pharmaceutical & Cosmetic Laboratory

• Performed sterility and MLT testing
• Conducted Microbial Identification and pathogen detection.
• Performed environmental monitoring
• Handled media preparation and GPT
• Ensured laboratory compliance with GLP, GDP and documentation requirements.
• Prepare and review microbiological documentation for regulatory submissions and audits (FDA, EMA, etc.)

M. Sc.

• MICROBIOLOGY - Chaudhry Charan Singh university (2024 - 2026)

B. SC (Hons) - MICROBIOLOGY - Shaheed Rajguru College of Applied Science for Women (2020 - 2023)

INTERMEDIATE (XII) - Government Girls Senior Secondary School (2018 - 2020)

HIGH SCHOOL (X) - Shaheed Smarak Public School (2017 - 2018)