Dhvani N. Patel
Mississauga,Canada
Summary
Experienced Quality and Regulatory professional with 9+ years of pharmaceutical industry background, specializing in Quality Assurance, Regulatory Affairs, and compliance documentation. Skilled in SAP operations, CTD dossier preparation, and audit readiness. Proven ability to work cross-functionally and deliver accurate, timely documentation aligned with global regulatory requirements.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Sr. Executive, Quality Assurance
Troikaa Pharmaceuticals Ltd.
01.2022 - 04.2024
- Ensured compliance with pharmaceutical quality standards, health and safety regulations, GMP, and GDP across manufacturing and distribution operations.
- Change Control Management: Oversaw the initiation, review, and timely closure of change control records, ensuring adherence to regulatory timelines and internal SOPs.
- Batch Documentation Review: Performed comprehensive reviews of executed batch manufacturing and cleaning records, ensuring accuracy, traceability, and alignment with CGMP and internal specifications.
- Batch Release: Authorized the release of intermediate, Semi Finished and Finished products batches following verification against approved specifications and production records.
- Deviation Management: Led the initiation, investigation, documentation, and closure of internal and external deviation reports. Ensured timely CAPA execution and compliance with deviation procedures.
- Root Cause Analysis & CAPA: Investigated non-conformances, including OOS and OOT incidents, using root cause analysis. Developed effective CAPAs to address underlying issues and mitigate recurrence.
- SOP & Training Oversight: Managed the preparation, review, approval, and version control of SOPs. Oversaw training compliance and documentation to ensure team-wide awareness of quality practices.
- Annual Product Quality Review (APQR): Compiled and summarized APQR reports in alignment with SOPs and regulatory expectations, highlighting product trends, deviations, and key quality metrics.
- Supplier & Inspection Documentation: Maintained and updated incoming inspection records and supplier master documentation, ensuring full compliance with quality standards and audit readiness.
- Audit Preparation & Vendor Audits: Supported preparation and readiness for internal, regulatory, and customer audits. Conducted vendor audits for raw material and packaging material suppliers in compliance with cGMP standards.
- Managed administrative duties such as filing and maintaining controlled quality documents to support regulatory compliance and effective document management.
- SAP (Systems Applications and Products in Data Processing) Activities: Development & Quality Environment Testing: Created and executed test cases in SAP development and quality clients. Documented testing results and supported qualification phases.
- SAP Master Data Management: Created and maintained master data for Raw Materials (RM), Packaging Materials (PM), Finished Goods (FG), Semi-Finished Goods (SFG), services, CAPEX items, and promotional/non-valuated materials. Ensured data integrity in collaboration with cross-functional teams.
- BOM & Recipe Maintenance: Developed and updated Bills of Materials (BOMs) and manufacturing recipes for SFG and FG, ensuring system accuracy and production readiness.
- Inspection Plan Management: Created and revised inspection plans and master inspection characteristics for FG/SFG in alignment with product specifications and quality standards.
- Resource & Cost Center Configuration: Configured and updated SAP resources, activity rates, and associated transactional characteristics for effective system integration.
- SAP SOPs & Training: Authored SOPs related to SAP master data management. Delivered user training and reviewed existing plant SOPs to ensure alignment with SAP transactions and regulatory practices.
- Change Control & Data Corrections: Issued and managed SAP-related change controls, error records, and data modification requests to ensure compliance, traceability, and data integrity.
Technical Assistant, Formulation & Development
Torrent Pharmaceuticals Ltd.
11.2014 - 07.2022
- Prepared, revised, and retrieved technical documentation for drug substances and products, including stability protocols and development reports.
- Drafted Common Technical Document (CTD) submissions for APIs, excipients, bulk and finished products in alignment with global regulatory guidelines.
- Managed Standard Operating Procedures (SOPs) in both electronic and physical formats using Training Management Software.
- Reviewed drug product data compiled by formulation scientists and supported product development report generation.
- Coordinated responses to regulatory queries and prepared trending data for submissions in the US, EU, ROW, and domestic markets.
- Initiated and managed change control documentation for product/process updates.
- SAP System Operations & Master Data Management: Conducted procurement planning and raw material forecasting based on formulation batch requirements for all development projects.
- Collaborated with vendors for material sourcing and evaluated availability and terms.
- Provided end-to-end SAP support across MM, QM, and PP modules, including issue escalation and resolution.
- Created and maintained SAP master data: materials (RM, PM, FG, SFG), Bill of Materials (BOM), recipes, resources, inspection plans, and specifications.
- Executed MRP activities, process order creation, availability checks, order confirmations, and stock management.
- Performed baseline batch management configuration and maintained batch traceability systems.
- Developed and implemented inspection characteristics, methods, sampling procedures, and usage decisions under SAP QM.
- Oversaw specification creation and updates for international markets (US, EU, Brazil, ROW), ensuring compliance and data accuracy.
- Supported technology transfers through SAP activities including code extensions, recipe management, and specification uploads.
- Facilitated material movements using stock transport orders and reservation activities for exhibit and commercial batches.
- Issued and managed change controls, error records, and change requests to maintain SAP data integrity across departments.
Trainee Regulatory Affairs Officer
Bonita Pharmaceuticals Pvt. Ltd.
08.2013 - 11.2014
- Prepared and reviewed regulatory dossiers for drug substances/products for the ROW market.
- Compiled and submitted Drug Establishment License (DEL) and Site License (SL) applications and managed labeling documentation.
- Drafted regulatory responses and post-approval change submissions.
QA/QC Intern
Gujarat Terce Laboratories Pvt. Ltd.
06.2013 - 07.2013
- Gained practical exposure to pharmaceutical quality control, documentation, and regulatory cycles.
Education
Bachelor of Pharmacy -
Gujarat Technological University
H.S.C - undefined
Gujarat Secondary and Higher Secondary Board
S.S.C - undefined
Gujarat Secondary and Higher Secondary Board
Skills
- Quality Management Systems – Deviation, CAPA, Change Control, APQR
- Knowledge of GMP and Health Canada Regulations
- Audit & Inspection Readiness (Internal, Vendor, Regulatory)
- Excellent Technical Writing and Documentation Control
- Regulatory Submissions & Dossier Preparation (CTD, post-approval changes)
- SAP MM/PP/QM module knowledge
LANGUAGES
English
Hindi
Gujarati
Certification
- SAP MM Certification – MLC College of Business, Technology and Healthcare (Mississauga, ON, CA) [Certificate No. : MLC/IND/PCC/20161031-0221
- ISO 14001:2015 & OHSAS 18001:2007 – Awareness Training (ISOQAR India Pvt. Ltd.)
- ISO 50001:2011 – Awareness Training (ISOQAR India Pvt. Ltd.)
Timeline
Sr. Executive, Quality Assurance
Troikaa Pharmaceuticals Ltd.
01.2022 - 04.2024
Technical Assistant, Formulation & Development
Torrent Pharmaceuticals Ltd.
11.2014 - 07.2022
Trainee Regulatory Affairs Officer
Bonita Pharmaceuticals Pvt. Ltd.
08.2013 - 11.2014
QA/QC Intern
Gujarat Terce Laboratories Pvt. Ltd.
06.2013 - 07.2013
H.S.C - undefined
Gujarat Secondary and Higher Secondary Board
S.S.C - undefined
Gujarat Secondary and Higher Secondary Board
Bachelor of Pharmacy -
Gujarat Technological University
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