SHIVA PARVATHI KANDULA
Hyderabad
Summary
Highly Inspired and experienced pharmaceutical Quality Assurance professional with over 8+ years of diverse Quality experience. Seeking a challenging position in a dynamic organization where I can leverage my expertise to drive innovation and achieve Operational excellence.
Overview
8
8
years of professional experience
Work History
Specialist (GQSI)
Novartis / Sandoz
06.2021 - Current
- Company Overview: SANDOZ is a global leader in generic pharmaceuticals and biosimilars
- It is the world's largest producer of generic antibiotics
- Extracted data from relevant sources in Sandoz tools/applications
- Interpreted the compiled external supplier PQR and extracted data from Internal Sandoz systems into a predefined template and drafted conclusions of annual product quality review
- Preparation, Review of Analytical Comparison report as per the EU requirement or any other contributory reports for APQR as applicable
- Process order management for procuring APQRs and Stability data using SRM/SAP application after Initiation of Shopping Carts for Procuring Documents from Suppliers as and when required
- Authoring and review of risk assessment reports for overdue documents
- Preparations of master plan schedules and revision of master plans as and wen required
- Managed the communications with stakeholders in a timely manner to ensure 100% deliverables
- Communicated with business owners to obtain feedback on services delivered
- SANDOZ is a global leader in generic pharmaceuticals and biosimilars
- It is the world's largest producer of generic antibiotics
Research Associate in Product Development Department, Biologics Division
Dr.Reddys Laboratories Limited
05.2019 - Current
- Responsible for extraction of data from Batch manufacturing Records (BMR or BPR) from work flow applications like SAP for compilation of data and documenting these as retrospective reports at regular intervals to support any process changes during product manufacturing
- Regularly communicating with Vendors or CRO’s for follow up of support services and keeps a track of scheduled activities to ensure their timely completion and execution
- Responsible for sample shipment to vendor or CRO site, review of reports for completeness and integrating with internal technical documents
- Responsible for preparation of specification documents, SOP, SDP, DRS for different methods based on method development data, IPQC and IP testing results
- To coordinate vendor qualification through audits, wherever necessary & evaluation of questionnaire and updating vendor approval list after obtaining relevant documents
- Perform device development studies for combination products as per ISO guidelines
- Coordinating equipment installation, qualification and preparation of validation protocols (IQ, OQ and PQ) as per 21 CFR and GAMP requirements
- Good knowledge on cGXP principles, 21 CFR part 11, 50,210,211, ICH guidelines
Scientist in Trace analysis Lab, Pharma division
Vimta Labs Limited
Hyderabad
10.2016 - 05.2019
- Preparation and review of Technical document like analytical validation and verification Protocols and Reports for extractable, leachable and nitrosamine testing as per EMA and FDA guidelines
- Ensuring availability of all the generated reports and regulatory relevant documents as per requirements and in compliance with current guidance
- General sample preparation of leachable and extractable as per USP 1663 and 1664 and PQRI guidelines
- Review and maintain the records related to change control, deviation, CAPA implementation and investigation of root cause that happened during execution of analysis as per prepared protocols and expected results
- Assist in inspections, Audits either internal or by various regulatory bodies
- Responsible for equipment management maintenance and calibration schedules of the instruments, coordination of vendor qualification and appropriate document handling
- Qualifying containers from different vendors and perform container closure selection studies for biologic drug products in different presentations like IV, SC and Lyophilized products
- Perform process characterization studies for DP manufacturing as per DOE process designs and data interpretations
- Extensive knowledge on analytical equipment’s like HPLC(PDA, RI, CAD) and IC for analysis of impurities (SEC,IEX) and also excipient content estimation in non-infringing biosimilar formulations and also MFI for sub visible particles and Variable path length spectrophotometer
- Preparation of Process description summary reports, Qualification protocols and reports, Validation protocols, Validation reports and other technical documents
- Comply with all internal functional operating procedures like time sheet management, quality procedures like usage of ELN for data recording and usage ilearn, islate, DOC hub and other safety initiatives like MSI and follow SHE guidelines and other compliance management systems and processes
Education
M.Pharm - Pharmaceutical Analysis And Quality Assurance
Mallareddy Institute of Pharmaceutical Sciences
Hyderbabad12-2014
Skills
- QMS tools
- Trackwise
- Agile
- 1QEM
- D2
- LIMS
- ELMS
- Planning
- Compiling
- Review of APQRs
- APQR stakeholder management
- Technical document writing
- Validation and verification Protocols
- Reports for Nitrosamine impurities
- Extractables and leachables
- Adapting regulatory requirements
Accomplishments
- Successfully implemented Process Order management (PO) and streamlined procuring documents (APQR, Stability data) from ESO suppliers.
- Played an active role as a team member in Optimizing APQR services, made a major contribution to the project by utilizing VBA (Macros) in excel to simplify the QMS query exports.
Timeline
Specialist (GQSI)
Novartis / Sandoz
06.2021 - Current
Research Associate in Product Development Department, Biologics Division
Dr.Reddys Laboratories Limited
05.2019 - Current
Scientist in Trace analysis Lab, Pharma division
Vimta Labs Limited
10.2016 - 05.2019
M.Pharm - Pharmaceutical Analysis And Quality Assurance
Mallareddy Institute of Pharmaceutical Sciences
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