Shweta Ray
Bangalore
Summary
Validation specialist experienced in US FDA-regulated pharmaceutical quality systems. Delivered comprehensive process cleaning equipment, HVAC, and computerized system validation deliverables with regulatory compliance and audit-ready documentation. Applied risk management methods to support effective deviations, CAPA execution, and timely task completion.
Overview
4
4
Languages
1
1
Certification
6
6
years of professional experience
Work History
Senior Officer, Quality Assurance (Validation)
Sun Pharmaceutical Industries Ltd.
Halol
02.2025 - Current
- Own validation and qualification activities across the full GxP lifecycle for manufacturing systems and equipment.
- Authored, reviewed, and approved validation documents including VMP, URS, FRS, FS, DS, risk assessments, FAT, SAT, IQ, OQ, PQ, RTM, validation summary reports, and system handover certificates to ensure compliance and quality.
- Drove HVAC qualification from DQ through FAT, SAT, and UAT to facilitate system release and support lifecycle management.
- Execute temperature mapping, coordinate filter integrity testing and oversee precision equipment calibration to keep equipment compliant and audit-ready.
- Represent validation as SME during regulatory audits.
- Partnered with vendors and cross-functional teams to ensure compliant and timely implementation of systems, enhancing operational readiness.
Formulation Executive
Torrent Pharmaceuticals Pvt. Ltd.
Dahej
06.2023 - 02.2025
- Reformulated solid oral dosage products and developed and optimized tablets, capsules and granules.
- Facilitated technology transfer from R&D to manufacturing while executing R&D, pilot, and feasibility batches to support product development.
- Authored and reviewed validation protocols and reports for process and cleaning, plus MFC, QFR, BMR, and eBMR entries in MES, ensuring compliance with regulatory standards.
- Resolved deviations and initiated CAPA, ensuring documentation met US FDA, EU GMP, and international standards.
- Trained QA, Manufacturing and R&D teams and supported audits with compliant documentation.
- Coordinated cross-functional batch execution and scale-up, and used SAP for batch activities and analytical data review.
Pharmacist
New Civil Hospital
Surat
04.2021 - 07.2021
- Reviewed medication orders for dosage, interactions, and prescription accuracy, and counseled patients on medicine use, side effects, and storage.
- Reviewed medication orders for dosage, interactions, and prescription accuracy.
- Assessed medication orders for accuracy and safety in pharmacy operations.
- Counseled patients on medicine use, side effects, and storage.
- Dispensed prescriptions for inpatient and outpatient civil hospital patients.
- Assisted in dispensing prescriptions for inpatient and outpatient services at New Civil Hospital pharmacy.
- Supported prescription dispensing under supervision in high-volume COVID care setting, while managing drug storage, labeling, inventory checks, expiry monitoring, and prescription records for patient safety and compliance.
- Monitored stock levels and reordered essential medicines.
Education
M.Pharm - Pharmaceutics
Anand College of Pharmacy
Anand Gujarat06-2023
B.Pharm - Pharmacy
AR College And GH Patel Institute of Pharmacy
Vallabh Vidyanagar Anand Gujarat06-2021
D.Pharma - Pharmacy
AR College And GH Patel Institute of Pharmacy
Vallabh Vidhyanagar Anand Gujarat06-2018
Higher Secondary 12th - Science Education
Lions Silk City
Surat Gujarat06-2016
10th - Science
D. A. V. Hindi School
Surat Gujarat06-2014
Skills
- Process validation
- Validation documentation
- Validation planning
- CSV documentation
- Risk assessment
- CAPA implementation
- CGMP compliance
- Audit support
- Quality management
- Data integrity management
- HVAC temperature mapping
- Filter integrity testing
- Technology transfer
- TrackWise management
- Change management collaboration
- Change management
- Change management
Personal Information
Title: Quality Assurance | Validation | CSV | QMS
Certification
Certification: Research and Publication Ethics
ADDITIONAL INFORMATION
Languages: English, Hindi, Gujarati, Marathi
Hobbies and Interests
Technical blogging, learning new technologies, driving
PROJECTS
- Off-side printing defect on tablets: Analyzed the printing process to find the root cause and implemented machine modifications to eliminate the defect, through the Quality Circle.
- Pulsatile drug delivery for acute cardiac events: M.Pharm project on design and optimization of the delivery system.
AWARDS AND RECOGNITION
Kaizen Award (twice) for process improvement initiatives, Sunshine Award for outstanding performance; Good Work Certificate (twice), Recognized twice in Safety Week competitions
Languages
English
Advanced (C1)
C1
Hindi
Native
Native
Gujarati
Proficient (C2)
C2
Marathi
Intermediate (B1)
B1
Affiliations
- Participated in Quality circle ad resolve the issue of off side Printing related issue on tablet surface
- 4Times Participated in Safety week Competition
Timeline
Senior Officer, Quality Assurance (Validation)
Sun Pharmaceutical Industries Ltd.
02.2025 - Current
Formulation Executive
Torrent Pharmaceuticals Pvt. Ltd.
06.2023 - 02.2025
Pharmacist
New Civil Hospital
04.2021 - 07.2021
M.Pharm - Pharmaceutics
Anand College of Pharmacy
B.Pharm - Pharmacy
AR College And GH Patel Institute of Pharmacy
D.Pharma - Pharmacy
AR College And GH Patel Institute of Pharmacy
Higher Secondary 12th - Science Education
Lions Silk City
10th - Science
D. A. V. Hindi School