SAP (Comet) & Coldstream CCM, Warehouse Management Systems (WMS), Business Intelligence (BI) Tool
Aparna Shinde
Quality Assurance
Kalyan-,Maharashtra
Summary
Quality Assurance professional with four years of experience in pharmaceutical logistics and repacking operations, dedicated to ensuring compliance with cGMP, GDP, and GxP standards. Expertise in deviation management, CAPA implementation, and documentation control has strengthened audit readiness, streamlined processes, and minimized non-conformities across supply chain operations. Proven track record of supporting QA excellence at MSD Pharmaceutical and Abbott St. Jude Medical through effective SOP implementation, internal audits, and validation of cold chain processes. Strong ability to foster cross-functional collaboration, uphold regulatory compliance, and drive continuous improvement in quality systems.
Overview
4
4
years of professional experience
3
3
Languages
Work History
Sr. Executive- QA
Abbott St. Jude Medical
Bhiwandi
01.2026 - Current
- Ensured compliance by verifying temperature and humidity data, housekeeping checklists, and insect control records in coordination with the principal company at defined frequencies.
- Authenticated and shared environmental monitoring data from Thermoclient and Backup Elitech loggers with Operations, internal QA team and ASJM SCM & QA team.
- Conducted thorough visual inspections of incoming products using standardized visual aids and license references, ensuring accurate identification and compliance. and verified damaged (Or any other descrepancy) goods to maintain product integrity.
- Conducted Random inspection during outward product checks against Invoice and LR/docket.
- Raised Change requests form for process changes, documements updates, equipment or system changes, facility changes, Regulatory or customer requirements & corrective actions.
- Guided Operations teams in completing Product Acceptance Forms in line with Abbott QA instructions for non-conforming products.
- Delivered structured training sessions to Operations staff, floor supervisors, and Quality team in alignment with the approved training calendar, maintaining accurate training records.
- Raised and managed Non-Conformities (NC), complaints, and Supplier Corrective Action Requests (SCAR), ensuring timely resolution.
- Maintained comprehensive documentation and records for warehouse validation and equipment calibration activities, ensuring compliance with regulatory standards and internal quality procedures.
- Ensured calibration schedules were adhered to, with accurate record-keeping for audit readiness and traceability.
- Initiated and tracked change controls in the system to align with quality standards.
- Drafted, revised, and reviewed Standard Operating Procedures (SOPs) and Work Instructions (WIs) with relevant stakeholders.
- Supported principal company representatives in QA and Operations-related activities.
- Responded to temperature alerts, investigated logger changes or fluctuations, and implemented corrective actions.
- Guided Operations teams in data sharing as per principal company requirements.
- Prepared and submitted Key Performance Indicators (KPIs) to the principal company QA team in accordance with procedures.
- Monitored and tracked non-conformities, quarantine materials, sales returns, and PER products.
- Verified quality and operational processes to ensure compliance with standards.
- Assisted Operations and principal company teams during audits, providing documentation and process support.
- Actively supported Operations teams to meet principal company expectations and maintain quality excellence.
IMQ ( In Market Quality)
MSD ( Merck Sharp and Dohme)
Bhiwandi
06.2023 - 01.2026
- Evaluated and reviewed temperature data from data loggers and verified critical shipment documents including Bill of Lading, Tax/Commercial Invoice, Bill of Entry, Certificate of Origin, Certificate of Conformance (COC), Certificate of Analysis (COA), Packing List, and customs warehouse records for imported consignments.
- Coordinated shipment testing by sending selected imported batches to government-approved laboratories (CDTL/CDL/NABL/NIB/ADC) for quality validation.
- Prepared and shared packing lists and Notification of Temperature Excursion (NTE) with manufacturing sites when excursions/incursions were observed in imported shipments.
- Released approved quantities of imported batches from Quality Inspection (QI) to Unrestricted status in SAP (Comet) upon receipt of Quality Notification (QN) and LG cancellation confirmation from supply chain management.
- Authorized nationwide distribution of cold chain (2–8°C) products after reviewing shipment temperature data, logger records, and compliance documents.
- Investigated temperature excursions and shipping delays by coordinating with CFA sites, super distributors, transport vendors, and central warehouses (CWH).
- Obtained batch-wise storage declarations from CWH and shipping sites in case of excursions/incursions, evaluated data, and issued Disposition Memos accordingly.
- Reviewed vehicle temperature data, release notes, and dispatch documents for non-cold chain (15–25°C) shipments, approving distribution across PAN India.
- Coordinated with transport vendors for non-cold chain vehicle mapping, calibration reports, and release notes.
- Supervised cold chain and non-cold chain consignment packing, verified thermographs of warehouse storage areas, and issued annexures for shipping materials.
- Monitored warehouse temperature conditions and maintained thermograph records for audit readiness.
- Oversaw Transportation Lane Risk Assessment (TLRA) activities for non-cold chain and validated box shipments.
- Performed internal audits in strict adherence to cGMP, SOPs, and regulatory guidelines, ensuring process integrity and compliance.
- Coordinated with manufacturing sites, supply chain management, CFA’s, super distributors, and transporters to resolve shipment issues, manage deviations, CAPAs, incident reports, and training records.
- Maintained monthly shipment dispatch data (imported and domestic) in Excel, and prepared KPI matrix reports, excursion tracking sheets, and release tracking reports for MSD Market Quality.
- Shared monthly KPI presentations, temperature excursion data, and documentation error tracking with MSD Market Quality and supply chain management.
Quality Assurance Officer
S.K. Logistics
Bhiwandi
04.2022 - 06.2023
- Granted line clearance and quality approval for stamping, stickering, overprinting, barcoding, scanning, QR code, logo printing, and MRP blocking activities across 18+ pharmaceutical product lines.
- Issued and managed Batch Packing Records (BPR) for stamp stock activities based on customer, trade, government hospital, and stockist requirements.
- Maintained comprehensive GMP documentation including pest and rodent control records, cleaning logs, Eurotherm-based thermographs, and health & hygiene records.
- Supervised monthly alarm testing activities and ensured accurate record-keeping for compliance and audit readiness.
- Reviewed and released BPRs to multiple pharmaceutical principal companies, ensuring adherence to quality standards.
- Conducted employee training sessions on SOPs, GMP, GDP, change controls, incidents, deviations, and product complaint handling.
- Oversaw cold chain and non-cold chain consignment packing, issuing annexures for shipping consignments to ensure regulatory compliance.
- Communicated with Principal Company QA teams to address product-related complaints and coordinate resolutions.
- Collaborated with transport vendors to review vehicle mapping and calibration reports, ensuring validated shipment conditions.
Education
MSc - Inorganic Chemistry
Ramniranjan Jhunjhunwala College
MumbaiBSc - Chemistry
B.K.Birla
KalyanHSC - undefined
Sarswati Vidyalaya & Jr. College
VasindSSC - undefined
Maharashtra State Board
Skills
Effective verbal communication
Team-oriented collaboration
Troubleshooting skills
Organizational time strategies
Meticulous attention to detail
Responsive to new challenges
Effective coordination skills
Technical Proficiency
Leadership & Training
Analytical Thinking
Collaborative teamwork skills
Service-oriented
Accomplishments
- Completed MS-CIT with 73%
- Certificate of National Talent Search Education Exam, 2011
Software
Interests
Singing
Painting
Fitness activities
Photography / creative arts
Timeline
Sr. Executive- QA
Abbott St. Jude Medical
01.2026 - Current
IMQ ( In Market Quality)
MSD ( Merck Sharp and Dohme)
06.2023 - 01.2026
Quality Assurance Officer
S.K. Logistics
04.2022 - 06.2023
BSc - Chemistry
B.K.Birla
HSC - undefined
Sarswati Vidyalaya & Jr. College
SSC - undefined
Maharashtra State Board
MSc - Inorganic Chemistry
Ramniranjan Jhunjhunwala College
Activities
Completed Industrial Visit in Chemistry, Ecotoxicology and Entomology Sections Conducted at Ross Life science Pvt. Ltd. Pune, 2018-04-06