Kamna Kumari

Overall 7 years of cross domain experience in the Life science /Pharmaceutical industry with extensive experience in handling documentation management system. Expertise in preparing and review of QMS documents i.e. Change control, Deviation and CAPA. Ensuring good documentation practices and quality of validation deliverables for GxP computerized system as per GAMP-5 guideline Ensuring regulations and industry standard including 21CFR 210, 211 and EU Annex-11and Data integrity.

• Completed certification on Computerised System Validation (CSV) from Udemy on 2022-06-05.
• Completed certification on SDLC overview from Udemy on 2022-06-12.
• Awarded as star of the month for contribution in query response for SFDA and TFDA regulatory agencies on Month of May 2022.

• International Journal of Advance Science and Technology
• ISSN:2005-4238 IJAST
• Vol 29, No.6 (2020).
• Pg : 8860-8866

• Authoring the validation deliverables like Master/Validation Plan, test plan and Validation Summary report
• Preparation and Review of Process validation and Analytical method validation protocol and report.
• Handled Agilent Technologies Equipment like HPLC and GC for analysis purpose
• Reviewing the User and Functional requirement documents and ensure the traceability within IQ,OQ,PQ Scripts.
• Conduct Internal checks and review change control. CAPA and deviation raised by respective team.
• Liase with internal, cross functional team as well as customer-facing meeting to understand design and automate the manual workflows currently happening within the labs.
• Providing first-line technical support for customer deployment
• Ensure for related change documentation, which is created or update during the change implementation, complies with Good Document Practice (GDP).
• Coordinate with related departments to ensure readiness of samples, reagents and documentation for dispatch at the time of regulatory submission including justification, NOC and other documentation.
• Faired knowledge of standard Instrument and Instrument software used in the Industry (e.g: Empower Chromeleon, Balance,pH meter.
• Faired knowledged of Informatic application used in the industry(LIMS,ELN etc)

• Software skills:
• Risk Assessment, Requirements & specification preparation, VP, IQ, POQ, Traceability matrix and validation summary report.
• Zen QMS and Track wise software for Quality management system for compliance.
• Slack collaboration tool.
• GC-Agilent technologies 6890 N, 7890 B, 8890 (Auto sampler) , GC- Agilent technologies Head space (GCHS) and GCHSMS-G1888, 7697A and 5977B (MSD) with Empower 3.0 and Open lab 2.2 software.
• HPLC system, 1200 series Agilent technologies. EZ chrome 2.0 software.
• Lab Vantage

• Project coordination with internal stakeholders and clients.
• Conducting status on outlook and zoom meetings
• Handled several projects/ delivery independently within stipulated timelines.