Jaykumar Sindhav
Parsippany,NJ
Summary
Methodical Quality Assurance Manager with superb problem-solving and quality skills. Keeps meticulous records and identify and troubleshoot problems. Specialties include operational improvements, program implementation and documentation.
Overview
8
8
years of professional experience
Work History
Manager - QA
LEADING PHARMA LLC
04.2021 - Current
- Monitored all operations that affect quality
- Managed over 25 quality personnel
- Handled change controls, deviations, Protocols, SOPs, batch records, APR and quality trainings
- Performed root cause analysis to identify and resolve quality issues and defects
- Investigated customer complaints and performed corrective actions to resolve quality issues
- Managed all communication with senior management to achieve all project objectives
- Developed test plans and perform troubleshoot on systems and analyzed test resources to resolve issues and managed communication with senior management to achieve objectives
- Developed strategies to achieve goals within given timelines
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards
- Collaborated with cross-functional teams to develop and implement process and system improvements.
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards
- Monitored staff organization and suggested improvements to daily functionality
- Conducted risk assessments to identify and mitigate potential quality issues
- Supervised and guided inspectors, technicians and other staff
- Facilitated proactive solutions by collecting and analyzing quality data
- Review current standards and policies
- Kept records of quality reports, statistical reviews and relevant documentation
Sr. Officer
SUN PHARMA. LTD
05.2015 - 12.2017
- Performed Analytical Method Validation
- Plant Troubleshooting activities and after-audit compliance activities
- Analytical method transfers to manufacturing plant
- Instruments calibration like HPLC, UV-visible Spectrophotometer
- Protocol and SOP preparation and review
- Literature survey and interpretation of data
- Solved FDA points for analytical methods related to impurity development
- Trained new employees in working group
Education
Master of Science - Strategic Management
University of Cumberlands
Williamsburg, Kentucky05.2024
Master of Science - Project Management
University of Cumberlands
Williamsburg, Kentucky08.2022
Master of Science - Regulatory Affairs of Drugs, Biologics and Medical Devices
Northeastern University
Boston, MA12.2019
Bachelor of Pharmacy -
Gujarat Technological University
Gujarat, India05.2013
Skills
- Employee Supervision
- Employee Training
- Current Good Manufacturing Practices (cGMP)
- Document Control
- Write Reports
- Troubleshooting and critical thinking
Timeline
Manager - QA
LEADING PHARMA LLC
04.2021 - Current
Sr. Officer
SUN PHARMA. LTD
05.2015 - 12.2017
Master of Science - Strategic Management
University of Cumberlands
Master of Science - Project Management
University of Cumberlands
Master of Science - Regulatory Affairs of Drugs, Biologics and Medical Devices
Northeastern University
Bachelor of Pharmacy -
Gujarat Technological University
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