Sunitha Edula

Core Competencies
• Computer System Validation (CSV) Lifecycle Management.
• Risk-Based Validation Approach as per GAMP 5
• Validation Documentation (VP, URS, FS, IQ, OQ, PQ, RTM).
• Regulatory Compliance – 21 CFR Part 11 & EU Annex 11.
• CSV Lifecycle using V-Model Methodology.
• GMP Documentation & Compliance
• Quality Management Systems (QMS)
• Data Integrity (ALCOA+)

•Experience on Computer System Validation Principles and lifecycle based on GAMP 5 methodology.
•Managed documentation lifecycle for Computer System Validation (CSV), including Validation plans, URS, FS, IQ, OQ, PQ, RTM ensuring compliance with GxP, GAMP 5, FDA 21 CFR Part 11 & EU Annex 11 requirements.
•Experienced in handling of change control management for Computer System Validation (CSV) activities.
•Performed Computer System Validation (CSV) activities for Learning Management Systems (LMS) in accordance with GAMP 5 and 21 CFR Part 11 requirements.
•Actively involved in supporting the Computer System Validation (CSV) lifecycle using the V-Model approach, from requirements documentation to System Validation and release.
•Understanding of data Integrity principles (ALCOA +) to ensure accuracy and reliability of electronic records.
•Designed and maintained document types, version control, review/approval workflows.
•Managed end-to-end document lifecycle including creation, review, approval, distribution, archival of GMP documents and audit-ready documentation in EDMS.
•Ensured compliance with Good Documentation Practices (GDP) and regulatory requirements.
•Maintained version control and audit trails within QMS systems.
•Reviewed SOPs, batch records, and quality documents for accuracy, completeness, and compliance.
•Supported internal and external audits by preparing and organizing documentation.
•Collaborated with Quality, Regulatory, R&D, Manufacturing, and IT teams to gather and document business and functional requirements.
•Ensured adherence to data integrity principles (ALCOA+) across documentation processes.
•Collaborated cross-functionally to update procedures based on CAPA outcomes, process improvements, and regulatory changes.
•Ensured laboratory audit readiness through routine checks, documentation accuracy, and corrective/preventive action implementation.
•Maintained audit-ready records across documentation, training, and validation activities, supporting successful inspections.

• Experienced in handling HPLC and UPLC.
• Experienced in performing Peptide mapping, IEX, SEC, Protein A and RP-HPLC for different mAbs &Non- mAbs.
• Experienced in performing LAL assay for endotoxin detection.
• Research project highlights.
• Method Development: Involved in SDS-PAGE & Western Blotting.
• Qualification: IRS Qualification of different mAbs.
• In process support for different mAbs & Non-mAbs through BCA assay, SDS-PAGE, OD280, SEC, Protein-A and IEX
• Purity analysis of SDS-PAGE gels through image lab software.
• Optimization of Forced degradation conditions (Oxidative stress, thermal stress, photo stress, high and low pH stress) and comparative stress stability studies of different mAbs
• Provides general laboratory support such as general instrumental cleaning, daily calibration & verification of pH meter and weighing balance, Annual calibration of HPLC, sample receiving, Storage of samples at respective temperature after analysis.
• IRS filling, labelling & its storage at respective temperatures.
• Documentation:
• Experienced in data compilation obtained from different analytical procedures, maintaining & trending the stability data for comparative studies.
• Involved in writing SOP of different instruments (HPLC, Western Blotting) and trained in writing technical reports.
• Trained on handling cIEF Maurice.

• Research Experience
• Project title: “Molecular modelling study of the effect of glycosylation on protein structure and dynamics”.
• Isolation of phloem lectin from the Legumes.
• Isolation and purification of proteins from various sources using affinity chromatography and SDS-PAGE.
• Microbiology: Basic cell culture, media preparation, culturing techniques, culture maintenance, aseptic techniques, pure culture techniques, identification techniques, staining and biochemical tests.
• Documentation: To handle DBT, DST and CSIR funded projects Symposium’s attended.
• Actively volunteered and participated in International biomolecular forms and functions on Jan, 2013 Organized by Dept. Of MBU, Indian Institute of Science Bangalore, India.

• Chemical Testing: Total Hardness, Alkalinity, Chloride, Sulphate, Nitrate, fluoride, Sulphide, Cyanide.
• Physical Testing: Appearance, colour, pH, odour, turbidity, TDS.
• Microbiological Testing of water through the membrane filter technique, Standard Plate Count, MPN, IMVIC and BOD.