BHUMI SHAH
Ahmedabad
Summary
Results-oriented Quality Assurance professional with expertise in regulatory compliance and CAPA management. Conducted PV system audits and GVP inspections, strengthening quality systems through cross-functional collaboration. Experienced in root cause analysis and driving compliance initiatives.
Overview
4
4
Languages
13
13
years of professional experience
Work History
PV-QA and QMS
Neocubes Pharma LLP.
12.2024 - Current
- Supported implementation and execution of PV QMS and PV System to enhance operational compliance.
- Performs PV QA audits of the PV System (activities, critical processes, vendors, etc.) and PV QMS.
- Managed PV-related deviations, quality issues, CAPA, effectiveness checks, and RCA to ensure regulatory compliance.
- Managed change control processes to ensure compliance with internal standards.
- Advises stakeholders on GVP Compliance Issues.
- Contributed to ongoing inspections readiness efforts and facilitated inspections for GVP compliance.
- Contributes to PV QA Audit Planning and support for QPPV.
- Ensured adherence to documentation practices for accuracy and consistency.
- Supports the compilation, maintenance, and ongoing reviews of the PSMF, if required.
- Overall QMS activities for Translation, Regulatory and PV department.
QMS and GMP Project Manager
Zenovel Pharma service LLP.
04.2022 - 12.2024
- Handled sponsor audits and monitored compliance.
- Conducted internal audits, prepared reports, and ensured CAPA implementation.
- Prepared compliance report and handled CAPA for sponsor audit.
- Effective client communication with timely GMP Audit updates, helps to manage their timelines; guide them for 'corrective actions to be taken by the site.'
- Resolved concerns and queries raised by sponsors and clients in a timely manner.
- Training of new QMS person and maintaining the Training Record of employees.
- Management Review meeting and its compliance
- Handling and Tracking deviations, Change Control, Archival, and IT backup.
- Reporting to management for day-to-day operation and challenges
- Ensured adherence to quality standards across all operations.
- Executed additional responsibilities assigned by management.
- Issued source documents to facilitate project tracking and compliance.
- Compilation of the source document after completion of monitoring.
- Conducting Monitoring Plan Meeting by a risk-based approach.
- Sharing the minutes of the meeting of MPM along with the important document protocol, scope, and drug literature
- Handling of SOPs (Prepare, Review, distribution, withdrawal, and archival)
QMS and CSV consultant
Sruta Solutions
Ahmedabad
05.2021 - 12.2021
- Developed and reviewed Computer System Validation deliverables in compliance with FDA 21 CFR Part 11, CFR Part 210, and GxP GLP, GCP, GMP compliance regulations.
- Validated processes by preparing, reviewing, and executing qualification IQ, OQ, and PQ; developed and reviewed validation plans, validation reports, and Traceability Matrix to ensure regulatory compliance.
- Developed and reviewed User Requirement Specifications (URS), Functional Requirements Specifications (FRS), and Requirement Traceability Matrix (RTM) to ensure alignment with project objectives.
- Created SOPs, protocols, and project plans to standardize processes and enhance compliance.
Admin Manager
Vandana English School
Ahmedabad
06.2019 - 04.2021
- Coordinated administrative support for staff, enhancing workflow efficiency.
- Oversaw procurement of stationery, books, and supplies, ensuring availability for educational needs.
- Students Fee Collection
- Facilitated meetings with parents to discuss student progress.
- Teachers Coordination
- Managed cultural activities agency coordination, fostering community engagement.
Sr. Executive – Quality Assurance
Zydus Cadila Healthcare Ltd.
Matoda
12.2015 - 05.2019
- Preparation of cleaning validation protocol and report, hold time study protocols and reports, Process validation protocols and reports.
- Managed Change Control (CC) processes, deviations, and incident reports, ensuring compliance with quality standards.
- Responsible for in process Quality Assurance activities & compliance of cGMP in manufacturing area.
- Preparation and review of APQR, Quality Index and Quality Matrix as per US FDA
- Managed the collection and analysis of Hold Time Study samples and swab samples for cleaning validation.
- Oversaw training programs and maintained training documentation, improving staff competency in quality assurance practices.
- Prepared, reviewed, and drafted SOPs for the QA department, enhancing procedural clarity and compliance.
- Review and approval of Batch Manufacturing Record and Batch Packaging Record.
- Review, preparation and approval of sampling protocol.
- Performance and review of trend analysis of Deviation, Incident, OOS etc.
- Review of quality documents like SMF, quality manual, and plant layout, etc.
- Responsible for the collection of QP samples, stability of retained samples during the packaging stage.
- Carry out in-process activities at all stages of manufacturing and packing.
- Withdraw in-process samples of blend, core tablets, coated tablet, capsule etc..
- Calibrate the IPQC instrument as per SOP.
- Carry out challenge tests of all packing machines as per frequency defined in SOP. Carry out stage wise LIMS activity.
- Conducted QA observations and rounds in manufacturing and packing areas to perform IPQA checks and ensure line clearance..
- Maintained oversight of new product management processes to ensure alignment with company goals.
- Performed transactions assigned to the Site QA administrator in ZyTIMS (Zydus training information management system) and exposure to Documentum software.
Analyst – Quality Assurance
Medico Labs Pvt. Ltd.
06.2013 - 12.2015
- Monitored and validated value chain process flow of granulation, compression, coating, mixing, filling through tests including weight variation, disintegration, hardness, thickness, and appearance checking.
- Prepared batch manufacturing records following GMP and ICH guidelines.
- Validated and amended master formulation records and SOPs in collaboration with QA and QC chemists; drafted costing sheet as per DPCO to support tendering process.
Education
PGDHM (Post Graduate Diploma) - Hospital Management
B.K. School of Management, Gujarat University
01-2020
Master of Pharmacy - Pharmaceutics
Sardar Patel University
V. V. Nagar, Gujarat01-2012
Bachelor of Pharmacy -
Saurashtra University
Rajkot, Gujarat01-2010
Diploma - Pharmacy
Saurashtra University
Jetpur, Gujarat01-2007
Skills
- Regulatory Compliance
- GVP compliance
- PV system audits
- Compliance auditing
- GVP inspections
- QMS Documentation Cleaning validation Drug formulation Pharmaceutical production Quality assurance
- Quality systems
- SOP management
- CAPA management
- Root Cause Analysis
- Risk management
- Audit strategy
- Cross-Functional Collaboration
Personal Information
- Title: PGDHM, M. Pharm (Pharmaceutics)
- Date of Birth: 1987-12-22
- Gender: Female
- Nationality: Indian
- Marital Status: Married
PERSONAL DETAILS
Language Known: English, Hindi and Gujarati
Languages
Language Known: English, Hindi and Gujarati
PROJECTS UNDERTAKEN
Formulation & evaluation of free flowing, respirable, biodegradable nano particles for site specific drug delivery in management of Asthma under the guidance of Dr. Tapan R. Shah, (Assistant Prof.) and Dr. D. K. Raval, (H.O.D, Dept. of Pharmaceutics, Sardar Patel University)
PUBLICATIONS
- Mouth Dissolving Tablet: Superlative Conclusive Dosage In Solid Form For Modern Age published in International Journal Of Pharmaceutical Science In July-Sept 2013 (vol-4, Issue-4)
- Formulation & evaluation of free flowing, respirable, biodegradable nano particles for site specific drug delivery in management of Asthma published in international journal of drug formulation and research in July-Aug -2013. (Vol-4, Issue-4)
Languages
English
Advanced (C1)
C1
Hindi
Advanced (C1)
C1
Gujarati
Native
Native
German
Beginner
A1
Timeline
PV-QA and QMS
Neocubes Pharma LLP.
12.2024 - Current
QMS and GMP Project Manager
Zenovel Pharma service LLP.
04.2022 - 12.2024
QMS and CSV consultant
Sruta Solutions
05.2021 - 12.2021
Admin Manager
Vandana English School
06.2019 - 04.2021
Sr. Executive – Quality Assurance
Zydus Cadila Healthcare Ltd.
12.2015 - 05.2019
Analyst – Quality Assurance
Medico Labs Pvt. Ltd.
06.2013 - 12.2015
PGDHM (Post Graduate Diploma) - Hospital Management
B.K. School of Management, Gujarat University
Master of Pharmacy - Pharmaceutics
Sardar Patel University
Bachelor of Pharmacy -
Saurashtra University
Diploma - Pharmacy
Saurashtra University