DEEKSHA S
QUALITY CONTROL EXECUTIVE - DOCUMENTATION | QMS | COMPLIANCE
Bangalore
Summary
Quality Control Executive with 4+ years of experience in Biologics QC, Documentation Management, Quality Management Systems (QMS), GMP Compliance and Audit Readiness in a USFDA, MHRA & EU GMP regulated environment. Skilled in SOP management, eLog implementation, quality events handling, CAPA, change control and ensuring inspection-ready documentation with strong adherence to Data Integrity (ALCOA+) principles. Experienced in analytical testing and preparation of specifications by referring to pharmacopoeias and regulatory guidelines.
Overview
4
4
years of professional experience
1
1
Certification
Work History
QC EXECUTIVE-DOCUMENTATION, QMS & ELOG
Biocon Biologics Pvt. Ltd.
Bangalore
06.2024 - Current
- Prepare, review and maintain GMP documents including SOPs, Wis, logbooks and controlled forms ensuring accuracy, completeness and compliance.
- Handle Quality Management System documentation for Deviations, CAPAs and Change Controls ensuring timely investigation and closure.
- Support internal, customer and regulatory audits (USFDA, MHRA, EU GMP) by ensuring audit readiness and retrieval of required documents.
- Actively involved in electronic Logbook (elog) implementation-process mapping, user training, validation and system rollout in QC laboratories.
- Ensure compliance with cGMP, Data Integrity (ALCOA+), GDP and internal quality SOPs.
- Work closely with QA, Manufacturing, Validation, IT and QC teams for process improvement and compliance excellence.
- Preparation of analytical specifications for raw materials, intermediates and finished products by referring to pharmacopoeias including USP, EP, BP, IP and regulatory guidelines.
- Ensure specification governance, periodic review and revision as per change control process.
QC ANALYST - IN-PROCESS SECTION
Biocon Biologics Pvt. Ltd.
Bangalore
07.2023 - 06.2024
- Performed in-process analytical testing using pH meter, Osmolality analyzer and HPLC.
- Ensured compliance with GMP, GLP and Data Integrity requirements in all activities.
- Maintained laboratory records, instrument logbooks and batch documentation.
- Supported troubleshooting and investigations for OOS/OOT results.
QC ANALYST - STABILITY SECTION
Biocon Biologics Pvt. Ltd.
Bangalore
05.2022 - 07.2023
- Executed stability studies as per approved protocols and testing schedules.
- Performed analytical testing using HPLC, pH and Osmolality methods.
- Maintained stability data, trends, reports and documentation in compliance with GMP.
- Assisted in investigations and contributed to process improvement initiatives.
Education
M.Sc. - Integrated Biotechnology
VIT University
01.2022
Skills
- Quality Management Systems (OMS)
- GMP & Regulatory Compliance
- SOP Management & Lifecycle
- Document Management (DMS)
- Audit Readiness & Inspection Support
- CAPA, Deviations & Change Control
- Electronic Logbook (elog) Implementation
- Data Integrity (ALCOA)
- Good Documentation Practices (GDP)
- TrackWise QMS
- Honeywell Platform (MES)
- BioQuest
- Risk Based Thinking
- Cross-functional Collaboration
- Continuous Improvement
- HPLC
- Osmolality Analyzer
- PH Meter
- QMS, CAPA, Deviations
- Change Control
- Audit Management
- SOPs, Wis, Logbooks
- DMS, elog, Controlled Documents
- Document Lifecycle Management
- CGMP
- GLP
- GDP
- Regulatory Guidelines (USFDA, EU GMP, MHRA, ICH, WHO)
- Strong attention to detail
- Proactive & result oriented
- Excellent documentation skills
- Analytical problem solving
- Effective communicator
- Team player with leadership ability
- TrackWise CMS
- DMS (Document Management System)
- Electronic Logbook (log)
- Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
- QMS Applications
- Document Control Systems
Websites
Certification
Medical Coding Certification
Accomplishments
- Successfully supported multiple internal & regulatory audits.
- Leading documentation activities for electronic Logbook (log) implementation in QC.
Languages
English
Tamil
Internship
Genetic Engineering Internship, 2019-05-01
Software And Tools
- Honeywell Platform (MES)
- TrackWise CMS
- BioQuest
- DMS (Document Management System)
- Electronic Logbook (log)
- Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
- QMS Applications
- Document Control Systems
Timeline
QC EXECUTIVE-DOCUMENTATION, QMS & ELOG
Biocon Biologics Pvt. Ltd.
06.2024 - Current
QC ANALYST - IN-PROCESS SECTION
Biocon Biologics Pvt. Ltd.
07.2023 - 06.2024
QC ANALYST - STABILITY SECTION
Biocon Biologics Pvt. Ltd.
05.2022 - 07.2023
M.Sc. - Integrated Biotechnology
VIT University