Seema Bharmota
Lansdale,USA
Summary
Quality Assurance and Quality Systems professional with over 7 years of experience in GMP-regulated pharmaceutical and clinical environments. Proven track record in batch record review, deviation investigations, CAPA management, and document control. Adept at ensuring regulatory compliance with FDA, cGMP, and ISO standards. Proficient in MS Office, SharePoint, and COSMOS with strong technical writing, root cause analysis, and audit readiness preparation skills.
Overview
7
7
years of professional experience
Work History
Quality Systems Associate – Product Release/Investigator
Accupac Inc.
09.2024 - 04.2025
- Reviewed batch records, test results, and documents to ensure compliance with cGMP, SOPs, and client specifications.
- Investigated deviations, OOS/OOT events using root cause analysis (RCA) and issued CAPAs.
- Managed document control systems, ensuring audit-readiness and regulatory alignment.
- Released bulk and finished goods after verifying all analytical and microbial results met specifications.
- Led investigations and authored clear, compliant reports using technical writing best practices.
Team Leader (Production Supervisor Equivalent)
Accupac Inc.
04.2024 - 08.2024
- Supervised production lines to meet QA and safety standards.
- Supported audits and line tests, coordinating between QA and operations teams.
- Conducted packaging line verifications and documentation reviews.
Senior Distribution Associate – Clinical Services
Almac Group
01.2021 - 01.2024
- Processed and verified clinical trial orders in COSMOS, ensuring GMP-compliant documentation and distribution.
- Collaborated with internal teams to troubleshoot order discrepancies and maintain quality assurance standards.
- Trained new hires and acted as senior QA liaison in logistics operations.
- Conducted document creation, review, and archiving as per regulatory guidelines.
On-Site Supervisor
AccuStaffing Services
01.2018 - 01.2021
- Managed team scheduling, compliance, and employee onboarding in a GMP-regulated warehouse.
- Performed root cause analysis and implemented corrective actions to streamline workflows.
- Ensured training adherence and workplace safety compliance across shifts.
Education
Bachelor’s Degree - General Study
Delhi University
New DelhiDiploma in Digital Electronics Engineering - Microprocessor Design
Board of Technical Education
New DelhiHigh School Diploma - Physics, Chemistry, Biology
DSSCE
New DelhiSkills
- Document Control
- Quality Assurance
- Batch Record Review
- Product Release
- Deviation Investigation
- OOS Investigation
- OOT Investigation
- CAPA
- Change Control
- GMP
- CGMP
- GxP Compliance
- Logbook Review
- Quality Systems Management
- SOP Development
- Regulatory Audit Support
- Root Cause Analysis
- International Logistics
- Software Proficiency
- Oracle EBS
- LIMS
- TrackWise
- Master DC
- EBR
- AccuTerm
- Aviante
- COSMOS
- SHIPEZ
- EDI
- LiveLinks
- Regulatory Compliance
- Leadership
- Training
- Customer Service
- Communication
- MS Office Suite
- SharePoint
- Document Management Systems
- ISO Compliance
- Technical Writing
- Audit Readiness
Timeline
Quality Systems Associate – Product Release/Investigator
Accupac Inc.
09.2024 - 04.2025
Team Leader (Production Supervisor Equivalent)
Accupac Inc.
04.2024 - 08.2024
Senior Distribution Associate – Clinical Services
Almac Group
01.2021 - 01.2024
On-Site Supervisor
AccuStaffing Services
01.2018 - 01.2021
Bachelor’s Degree - General Study
Delhi University
Diploma in Digital Electronics Engineering - Microprocessor Design
Board of Technical Education
High School Diploma - Physics, Chemistry, Biology
DSSCE
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