Nalini P. Priya
Senior Quality Assuarance
Hyderabad
Summary
Highly motivated and experienced professional with a strong background in quality assurance. Applies skills and relevant experience to drive tangible results and contribute to the overall growth of the organization. Committed to achieving targets and ensuring genuine progress in a responsible and suitable position.
Successful Senior Executive with over 8 years of demonstrated ability in delivering mission-critical results. Offering outstanding communication and cross-cultural team management skills.
Overview
8
8
years of professional experience
9
9
years of post-secondary education
3
3
Languages
Work History
Senior Executive - QA
Invitron Advanced Analytics Pvt. Ltd.
12.2015 - 02.2024
- Change control management and effectiveness.
- Preparation, coordination and implementation of SOP's.
- Handling of QMS documents.
- Assists with writing SOP's and make recommendation of SOPS revision for quality operations and supported department.
- Carried out internal audits, third party audits as and when required as per schedule and preparation of report and monitoring the compliance of the actions as mentioned in the reports.
- Facilitating with the help of cross functional teams for implementing the QMS principles.
- Handling of incidents, deviations, OOS.
- Facilities CAPA commitments and effectiveness checks including initiation, tracking, trending and closure track. And management of deviation, incidents, CAPA systems trending and track wise.
- Management of Training activities.
- Maintained QA logbooks for document issuance, change control, incidents, deviations and CAPA.
- Receiving, ensuring and registering of Samples received from third party.
- Review of various documents like Review of Qualification documents of Equipment's and Management of equipment calibration, qualification, and maintenance program.
- Review of documents like SOPS, analytical protocols, reports, specifications and STPS.
- Reviewing of analytical data of development, validation, Quality control, Stability, elemental analysis, IVRT and IVPT study.
- Audit trail review: HPLC with software Open lab and empower, ICPMS with software Mass Hunter, IC with software Chromeleon, LCMS with software Mass Hunter and Analyst & GC with software Open lab.
- Audit Experience (Regulator): Prepared the facility for regulatory audit with the team for successful compilation of USFDA (SEP 2018 and JAN 2023)
Education
Master of Science -
Chemistry
04.2001 - 01.2010
BSC - Microbiology,Biochemistry,Chemistry
Skills
Quality management systems
Team management
Documentation review
Auditing expertise
Review of Analytical Raw Data
Handling Incidents and Deviation
CAPA management
Risk analysis and mitigation
Internal audits
Audit coordination
Document control
Complaint investigation
Regulatory compliance
Disclaimer
I hereby declare that all the information furnished above is true to the best of my knowledge.
Personal Information
- Date of Birth: 10/20/87
- Nationality: Indian
- Marital Status: Married
Timeline
Senior Executive - QA
Invitron Advanced Analytics Pvt. Ltd.
12.2015 - 02.2024
Master of Science -
Chemistry
04.2001 - 01.2010
BSC - Microbiology,Biochemistry,Chemistry
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