TECHNICAL SKILLS / SOFTWARE KNOWLEDGE CAPS Application – PM, Calibration, Temperature Mapping & Validation Tracking Quality Management System (QMS) – Change Control & Documentation Handling SAP – Material & Maintenance Coordination (if applicable) LIMS – Laboratory Information Management System (if applicable) BMS / EMS – Building & Environmental Monitoring Systems (Area Monitoring & Compliance) MS Office Suite – Word, Excel, PowerPoint Documentation Control & Data Management
D. Lavanya
Validation & Documentation Executive – Pharmaceutical Industry
Anakapalli District
Summary
Documentation and Validation professional with 6.9+ years of experience in pharmaceutical manufacturing (API). Experienced in equipment qualification, temperature mapping, preventive maintenance documentation, calibration review, and regulatory audit support including US FDA, Russian, Japan, and GMP Schedule-M audits. Strong knowledge of QMS systems, validation protocols, and compliance documentation.
Overview
8
8
years of professional experience
2
2
Languages
Work History
Honour Lab Limited – Unit III
08.2018 - Current
- Preparation and execution of Temperature Mapping protocols and reports for facilities and equipment
- Preparation of Equipment Qualification documents (DQ, IQ, OQ)
- Preparation and review of SOPs, Preventive Maintenance Schedules, and Calibration Schedules
- Review of calibration certificates and traceability documentation
- Review of cleanroom re-validation documents
- Preparation and review of Utility Validation protocols and reports (Compressed Air, Breathing Air, Nitrogen)
- Initiation and tracking of Preventive Maintenance, Calibration, Re-qualification, and AHU Re-validation activities in CAPS system
- Change control initiation for facility modifications in QMS
- Support during internal and external regulatory audits
Education
B.Tech -
KLM College of Engineering for Women
KadapaIntermediate - undefined
Sri Chaitanya Junior College
TirupatiSSC - undefined
Pavan High School
KadapaSkills
- Equipment Qualification (DQ, IQ, OQ)
- Re-Qualification & Re-Validation
- Temperature Mapping (Controlled & Uncontrolled Areas)
- Preventive Maintenance Scheduling
- Calibration Documentation & Review
- Utility Validation (Compressed Air, Nitrogen, Breathing Air)
- SOP Preparation & Documentation
- Change Control Management
Software
DECLARATION
I hereby declare that the information provided above is true and correct to the best of my knowledge. D. Lavanya
REGULATORY AUDITS FACED
- GMP Audit – Drug & Cosmetic Act 1940 (Schedule-M)
- Russian Regulatory Audit
- US FDA Audit (2019)
- Japan Regulatory Audit
PERSONAL DETAILS
- Date of Birth: 25 June 1991
- Gender: Female
- Marital Status: Married
Timeline
Honour Lab Limited – Unit III
08.2018 - Current
Intermediate - undefined
Sri Chaitanya Junior College
SSC - undefined
Pavan High School
B.Tech -
KLM College of Engineering for Women