MANSI SHAH
Lancaster,PA
Summary
Over 10 years of experience in quality assurance and regulatory affairs Dept. Strong background in cGMP, SOP, handling regulatory queries and complaints. Proven skills in performing internal audits, initiating CAPA-NCRisk reviews, commissioning/decommissioning of laboratory instruments, Validation of GMP software's. Experienced in maintaining calibration schedule of lab instruments and interdepartmental KPIs. Experienced in providing regulatory strategies and GMP/GLP training that integrates with company objectives. Demonstrated ability to work on multiple projects and excel with teamwork to meet final goal.
Overview
12
12
years of professional experience
Work History
Process Development Quality Tech
Biovectra Inc.
11.2022 - Current
- Opening, maintaining and review of Change controls in various software's like Master control, BMRAM, QMS
- Commissioning/decommissioning of Lab equipments
- Maintaining record of all the laboratory instruments, assigning their IDs, creating their calibration schedules and work plan templates
- Collect samples for detection of viable (surface,growing and air) and non-viable air particles.
- Maintaining departmental KPIs and participating in Int.Audits
- Championed data integrity by maintaining and completing all required documentation with meticulous accuracy, adhering to current Good Manufacturing Practice (GMP) regulations as per ALCOA
- Preparing and updating various controlled documents
- Reviewing and approving document changes based on audit findings in Master control
- Reviewing and approving incidents, CAPA, Risk reviews, NCs entered in Unipoint
- Reviewing and approving Calibration/Maintenance forms performed by different departments using BMRAM
- Provide internal training to beginners.
QA Validation associate
Biovectra Inc.
08.2020 - 11.2021
- Preparing, revising, reviewing and launching of Documents and SOPs
- Performing facility inspections
- Aseptic process monitoring with clean room equipment
- Supporting validation and qualification application which includes computer systems, equipment qualification and policies to ensure facility and site compliance
- Drafting protocol for Validation and qualification activities of softwares and their execution
- Performed evaluation of the classified areas with regards to fit and finish.
- Supporting Equipment Risk review
- Collect and submit samples for TOC, Conductivity, microbial count and endotoxins
- Deviation and its review
- Participating in internal audits.
QA Executive
B&S Healthcare
04.2015 - 07.2019
- Implemented and updated SOP to ensure cGMP compliance and product quality as per industry regulatory requirements
- Handled incidents, change controls, deviations and complaints through well-established procedure and addressed the same
- Prepared quality documents and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations using various statistical process control tools
- Provided training to newly joined employees and conducted orientation in related areas
- Managed the day-to-day activities of the QA specialist including assignment of tasks/duties, monitoring of work quality and productivity.
Assistant Professor in Pharmaceutical analysis
Pioneer pharmacy college
06.2012 - 04.2015
Education
Masters in Pharmaceutical Analysis -
Gujarat Forensic Science University, Gandhinagar, India
Bachelor of Pharmacy -
Gujarat University, India
Higher secondary education (grade 11-12) -
Secondary education (upto Grade 10) -
Skills
- Aseptic Gowning Technique
- Change Control
- Deviations
- Risk Review
- Equipment Maintenance and Calibration
- Unipoint, QMS, Master Control, Blue Mountain
- Continuous Quality Improvement
- Environmental Monitoring (Air, Surface, Swab)
- Inventory Management
- SOP Development and Implementation
Timeline
Process Development Quality Tech
Biovectra Inc.
11.2022 - Current
QA Validation associate
Biovectra Inc.
08.2020 - 11.2021
QA Executive
B&S Healthcare
04.2015 - 07.2019
Assistant Professor in Pharmaceutical analysis
Pioneer pharmacy college
06.2012 - 04.2015
Masters in Pharmaceutical Analysis -
Gujarat Forensic Science University, Gandhinagar, India
Bachelor of Pharmacy -
Gujarat University, India
Higher secondary education (grade 11-12) -
Secondary education (upto Grade 10) -
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