Divya Amalla
CSV Professional
Hyderabad,Telangana
Summary
Over 10 years experienced, Trainer,
Lean Six Sigma Green Belt, GMP
Compliance & Auditor result-oriented,
hardworking Quality Management
professional. Expertise in project Quality assurance and Quality Control functionalities in Pharmaceutical API, Sterile
manufacturing & CRO Industry. Well versed in different CSV projects (ERP- LIMS, eQMS, eLMS, eDMS, SCADA,etc) .Currently I am working for software development company and looking forward to pursue a role as
Computerized System Validation / Computerized Software Assurance
consultant project in IT service industry to accomplish my competent life science (Pharmaceutical) insights & quality skills for software compliance as per the regulatory and different control standards (Eudralex-
EMA, EU GMP, USFDA, GDPR, HIPAA ,
HITRUSTetc.) requirements
Overview
10
10
years of professional experience
Work History
Analyst II-CSV & IA ,IT
Curia Global Pvt Ltd.(formerly AMRI )
Hyderabad
09.2024 - Current
- Computer System Validation, Internal and External Audit-Compliance, Training, Quality Management System - Deviation, CAPA, Incident Management, Sterility Assurance & Compliance, Risk Management & mitigation Plan, CAPA Effectiveness checking, Internal Audit, GxP Gap Assessment.
- Responsible for Cloud (SaaS) Validation package (Requirement Matrix, Traceability Matrix, and Risk Register review and preparation. Responsible for reviewing IT security specifications. Responsible for preparation of different automation tool validation documents. Responsible for performing Risk Assessment and validation plan.
- Responsible for planning for Annual Training planner and actively working with different stakeholders. Responsible for Internal & External Audit and related CAPA plan. Supplier assessment and verification of SLA. Impart training on different regulatory guidance to all stakeholders. Responsible for SOP, Policy preparation and review. Responsible for defects and deviation management process.
- Actively participated in various CSV projects, from validation plan to execution.
- Collaborated with cross-functional teams on projects related to analytics initiatives.
- Maintained positive working relationship with fellow staff and management.
- Set specific goals for projects to measure progress and evaluate end results.
- Organized client meetings to provide project updates.
- Summarized Participated Work life cycle Framework: Vendor & Supplier Assessment and vendor qualification as per Quality management system. Responsible for audit report preparation and issuance report to different pharmaceutical GMP facilities. Responsible for reviewing different CAPAs as per the given observation. Responsible for approval of new user in Empower 3.6.1 and other software. Responsible for review of CSV document compliance as per EU Annex 11, 21 CFR Part 11 - URS/DS/FS/IQ/OQ/PQ, and VSR (Validation summary report). Responsible for reviewing RTM, Discrepancy matrix (Requirement Traceability matrix), SDLC, and FRS (Requirement Matrix). I have expertise in GXP Gap assessment, Quality risk assessment and mitigation plan for compliance. Responsible for Data Integrity (ALCOA+) and GDP compliance. Responsible for GAMP assessment categorization as per CAT3, CAT4, and CAT5, etc.
- Responsible for periodic restoration, verification, and risk assessment, as per inventory. Also responsible for reviewing change management of system, server backup software, etc. Responsible for deviation management and CAPA implementation.
Senior Executive-Quality
Aspiro Pharma ltd.
Hyderabad
06.2017 - 09.2021
- Actively participated in various CSV projects, from validation plan to execution. I am responsible for deviation management, CAPA implementation, and effectiveness evaluation as per regulatory requirements. I procure reagents and chemicals through purchase orders. I participated in regulatory audits (USFDA, KFDA, EDQM, and GCQA). I handled out-of-limit investigations during equipment validation. I handled laboratory incidents and OOS during operation. I qualified vendors and assessed them through analysis as per checklist evaluation strategy. I ensured calibration status as per the monthly schedule. I qualified the clean room. I executed MLT method validation. I executed BET method validation.
- Actively involved in validation of water system, preparation and review of protocol and SOP. Imparted training to onboard employees (Tracking of Induction, Initial Qualification, Specimen signature, and TNI). Involved in Clean room Qualification. Impact assessment for Sterility Assurance. Aseptic process simulation. Preparation of Annual trends of Quality notifications. Determination of the alert action limit determination in EM data.
Team Member-Quality Control & Microbiology
Dr.Reddys laboratories
Hyderabad
06.2011 - 06.2014
- I am responsible for monthly periodic audit trail review verification of all Empower-enabled HPLC instruments. I am responsible for imparting training on monthly cGMP and preparation of training matrix for ongoing, initial, and ad hoc sessions. I am actively involved in CAPA closure with respect to audit observations. I perform risk assessment and impact assessment analysis during change and deviation management. I also manage microbiological complex equipment and maintain a relationship with the supplier/vendor as per URS.
- Participation in regulatory (CDSCO, WHO-GMP, and CQA) audit and post-audit CAPA preparation. Participation in in-process quality assurance during aseptic simulation. Proactively involved in local regulatory agencies (CDSCO, Indian FDA, etc.). I Qualification and monitoring of personnel through routine schedule process during Aseptic process simulation. I ensure and execute Sterility of Dry powder injections, Bacterial Endotoxin Test (BET), Microbial Limit Test (MLT), Environmental monitoring of clean room of sterile manufacturing system, and Water system qualification and routine testing.
- Participated in regulatory Audits (USFDA, KFDA,
EDQM and GCQA ) I Personnel Qualification and data compilation I Handling
Out of Limit investigation during validation of equipment I Handling of
Laboratory Incidents and OOS during operation I Qualification of Vendors and
assessment through analysis as per checklist evaluation strategy I Ensure
calibration status as per monthly schedule I Qualification of Clean room I
Execution of MLT method validation I BET method validation I
Education
Master of Science - Organic Chemistry
Acharya Nagarjuna University
Telangana03-2013
Skills
- Trend Analysis
- Regulatory Compliance
- BI dashboards
- Workflow Analysis
- Audit Support
- MS Excel
- Data Quality Management
- Project Management
- Report Preparation
Languages
English
First Language
Timeline
Analyst II-CSV & IA ,IT
Curia Global Pvt Ltd.(formerly AMRI )
09.2024 - Current
Senior Executive-Quality
Aspiro Pharma ltd.
06.2017 - 09.2021
Team Member-Quality Control & Microbiology
Dr.Reddys laboratories
06.2011 - 06.2014
Master of Science - Organic Chemistry
Acharya Nagarjuna University
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