Deepika Kathirvel
Greenbank,QLD
Summary
A diligent client-focused Operations Specialist with experience in various facets of GMP Pharmaceutical environment such as QC, OPS and Quality Management (as well as leadership). A Critical thinker that cultivates rapport with stakeholders to resolve complex problems, deliver innovative improvement strategies.
Overview
8
8
years of professional experience
Work History
Operations Specialist
Viatris
Carole Park, QLD
08.2024 - Current
- Lead routine Root Cause Analysis meetings with stakeholders to assess operational incidents.
- Coordinated with core management team to analyze immediate containment actions and propose long-term preventative measures, enhancing operational reliability.
- Developed risk assessment reports for implementation of new operational processes, ensuring compliance and efficiency.
- Collaborated with cross-functional teams to identify gaps and evaluate compliance with regulations.
- Managed ongoing CAPAs with internal stakeholders, proposing process improvements to align with GMP quality standards.
Manufacturing Team Lead
Thermo Fisher Scientific
Woolloongabba, QLD
01.2024 - 08.2024
- Expertise in executing GMP critical batch manufacturing unit and manual operations.
- Supervised team members, ensuring compliance with safety protocols and quality standards to maintain operational integrity.
- Facilitated daily production meetings to coordinate team activities and resolve issues, promoting effective communication.
- Trained colleagues on equipment and analytical processes, enhancing their operational competence.
Senior Bioprocess Scientist
Thermo Fisher Scientific
Woolloongabba, QLD
09.2021 - 12.2023
- Identified and resolved process and equipment issues, documented workarounds and solutions for future reference.
- Developed troubleshooting guides for SAP by design and Smartsheets, enhancing user support for inventory and production management.
- Conducted experiments to analyze scientific data and validate research findings.
- Collaborated with cross-functional teams to develop innovative solutions in laboratory settings.
- Utilized advanced analytical techniques to interpret complex biological samples effectively.
Bioprocess Scientist
Thermo Fisher Scientific
Woolloongabba
08.2020 - 08.2021
- Performed unit and manual operations following media buffer and preparations protocol to ensure compliance and operational efficiency.
- Documented experimental results to meet regulatory requirements and support data integrity.
- Conducted experiments to analyze chemical reactions and biological processes.
- Collaborated with cross-functional teams to develop innovative research methodologies.
- Utilized advanced laboratory equipment for precise data collection and analysis.
QC Scientist (Microbiology)
Thermo Fisher Scientific
Woolloongabba
07.2019 - 01.2020
- Executed routine sampling of Water for Injection (WFI) and QC-Milli-Q water purification system; conducted bioburden testing on batch samples, process intermediates, and final filtration buffer samples to ensure microbiological quality.
- Recorded, analysed, and interpreted data to generate comprehensive test records, facilitating informed decision-making in quality control processes.
- Performed laboratory duties including sample receipt, media preparation for settle plates, and environmental testing of clean room suites to support compliance with quality standards.
QA Assistant (Intern)
TetraQ Bioanalytical
RBWH
01.2019 - 07.2019
- Validated immuno assay-based computerized systems (Magellan Tracker, Elpro) for pre-authorization of use, including URS, system description, risk assessment, vendor assessment, CAPA, periodic review, and AoU.
- Designed templates for logbooks and labels for sample receipt, ensuring compliance with change control procedures.
- Conducted routine quality checks on bioanalytical samples and processes.
- Assisted in developing and implementing quality assurance protocols and procedures.
- Collaborated with laboratory staff to ensure compliance with regulatory standards.
Student Researcher (Pathology)
Queensland Alliance for Agriculture and Food Innovation (QAAFI)
Dutton Park
07.2018 - 01.2019
- Performed routine plate reads, incubated samples, and documented results in logbook to ensure accurate tracking.
- Executed qPCR and ELISA assays to analyze samples, contributing to research findings.
- Analyzed data using statistical tools to support research findings.
Education
Masters - Biotechnology
University of Queensland
12-2019
Bachelors - Plant Biology and Plant Biotechnology
University of Madras
India05-2017
Skills
- GMP compliance
- Process optimization
- Risk assessment
- Root cause analysis
- Team Leadership and resource management
- Cross functional collaboration and team engagement
- Strategic communication and influencing skills
- Sound Problem solving skills
Timeline
Operations Specialist
Viatris
08.2024 - Current
Manufacturing Team Lead
Thermo Fisher Scientific
01.2024 - 08.2024
Senior Bioprocess Scientist
Thermo Fisher Scientific
09.2021 - 12.2023
Bioprocess Scientist
Thermo Fisher Scientific
08.2020 - 08.2021
QC Scientist (Microbiology)
Thermo Fisher Scientific
07.2019 - 01.2020
QA Assistant (Intern)
TetraQ Bioanalytical
01.2019 - 07.2019
Student Researcher (Pathology)
Queensland Alliance for Agriculture and Food Innovation (QAAFI)
07.2018 - 01.2019
Masters - Biotechnology
University of Queensland
Bachelors - Plant Biology and Plant Biotechnology
University of Madras