Saiteja Madasu
Middlesbrough,North Yorkshire
Summary
Results-driven QC Laboratory Analyst / Quality Control Microbiologist with 4+ years of experience in pharmaceutical and food manufacturing environments. Experienced in routine laboratory analysis, GMP & cGLP compliance, raw material and stability sample testing, environmental monitoring, deviation investigations, and CAPA management within highly regulated laboratories. Skilled in quality documentation, audit readiness, SOP review, analytical testing support, and laboratory systems including LIMS and Empower. Strong ability to work collaboratively across Quality, Production, and Validation teams to ensure compliance, operational efficiency, and timely product release.
Overview
7
7
years of professional experience
5
5
years of post-secondary education
1
1
Certification
Work history
QC Laboratory Analyst
DR. Reddy's
Mirfield, Kirklees
2025.06 - Current
- Performed routine quality analysis on raw materials, in-process samples, and finished products in accordance with GMP and food safety standards.
- Supported day-to-day laboratory operations by ensuring timely sample analysis, documentation review, and data reporting.
- Maintained accurate laboratory records and electronic documentation in compliance with ALCOA+ data integrity principles.
- Assisted with deviation investigations, non-conformances, and CAPA activities to support compliance and operational efficiency.
- Participated in SOP reviews, COSHH assessments, and risk assessment activities within the laboratory environment.
- Supported internal audits, hygiene inspections, and quality assurance activities aligned with HACCP, BRC, and GMP requirements.
- Worked collaboratively with Production, QA, and Quality teams to ensure smooth workflow and timely product release.
- Contributed to continuous improvement initiatives, laboratory housekeeping, and compliance activities within a fast-paced manufacturing environment.
Quality control microbiologist
Bharat biotech
Genome valley, India
2019.07 - 2023.08
- Performed microbiological analysis of raw materials, water samples, finished products, and stability samples according to USP, EP, and internal specifications.
- Conducted Sterility Testing, Microbial Limit Testing, Bioburden Analysis, and Endotoxin (LAL) Testing for pharmaceutical products.
- Executed Environmental Monitoring activities including viable air, surface, personnel, and water monitoring within classified cleanroom environments.
- Supported Deviation Management, OOS/OOT investigations, and CAPA implementation within GMP-regulated laboratories.
- Participated in cleanroom qualification, HVAC validation, autoclave qualification, and equipment validation activities.
- Assisted with SOP preparation/revision, validation documentation, analytical records, and audit readiness activities.
- Worked in compliance with cGMP, GDP, and Data Integrity requirements within highly regulated pharmaceutical manufacturing environments.
- Collaborated with QA, Production, Engineering, and Validation teams to support batch release, laboratory compliance, and continuous improvement initiatives.
Education
Master of Science - Microbiology (with advanced practice)
Teesside University
Middlesbrough 2023.09 - 2025.05
Bachelor of Science - Biotechnology
Bhavans vivekananda college
Hyderabad, India 2016.05 - 2019.05
Skills
- Routine Analysis of Raw Materials, IPC & Stability Samples
- GMP & cGLP Compliance
- Analytical & Classical Laboratory Techniques
- Basic Exposure to Chromatographic Techniques
- Deviation Management & CAPA
- OOS/OOT Investigation Handling
- Environmental Monitoring (EM)
- Data Integrity (ALCOA)
- SOP Review & Documentation Control
- Risk Assessments & COSHH
- Laboratory Audit Support & Inspection Readiness
- Sample Preparation, Analysis & Result Reporting
- LIMS & Empower Software Exposure
- Laboratory Documentation & Data Reporting Tools
- MS Office Suite (Excel, Word & PowerPoint)
- Equipment Qualification & Validation Support
- Trend Analysis & Quality Metrics Monitoring
Certification
- Level 3 Food Safety Certificate – Dr. Reddy's
- Level 3 Food Hygiene & Safety in Manufacturing – HighSpeedTraining.co.uk
- GMP & GDP Awareness Training - Dr. Reddy's
Timeline
QC Laboratory Analyst
DR. Reddy's
2025.06 - Current
Master of Science - Microbiology (with advanced practice)
Teesside University
2023.09 - 2025.05
Quality control microbiologist
Bharat biotech
2019.07 - 2023.08
Bachelor of Science - Biotechnology
Bhavans vivekananda college
2016.05 - 2019.05