Nisha .
Chandigarh
Summary
Enthusiastic and disciplined B.Pharm graduate with 5 years of pharmaceutical industry experience.
Seeking to contribute quality expertise to a leading pharmaceutical organization.
Overview
5
5
years of professional experience
Work History
Executive-QA
Shamshree Lifesciences Ltd.
Baddi
04.2025 - Current
- Handling end-to-end QMS operations, including Change Control, Deviations, CAPA, and quality documentation.
- Responsible for audit compliance through effective coordination, documentation review, and corrective actions.
- Actively involved in shop floor QA activities, SOP preparation, review, and employee awareness by giving trainings.
- Conducting BMR/BPR records reviews, verifying critical process parameters, documentation accuracy, and GMP compliance prior to batch release.
Asst. Executive-QA Documentation
Akums Pure And Cure Healthcare Pvt. Ltd
Haridwar
01.2024 - 03.2025
- Proficient in QMS Documentation Deviation, CAPA, Change Control, Incident, Handling cGMP compliance, documentation, SOP handling of small volume parentrals.
- Streamlined change control documentation flow and coordinated with cross-functional teams, resulting in faster closure rate and improved regulatory compliance.
- Encountered repeated line incidents due to equipment malfunction; initiated root cause investigation and coordinated maintenance actions.
Officer- Production Chemist
Zee Laboratories Ltd
Paonta Sahib
02.2021 - 12.2023
- Skilled in sterile area operations, cleanroom protocols, and aseptic practices.
- Proficient in batch documentation, equipment operation (autoclave, vial washing, tunnel, filling), and compliance with cGMP and WHO-GMP standards.
- Approved Manufacturing Chemist for SVP dosage forms.
Education
B. Pharmacy -
Lovely Professional University
01.2021
Skills
- QMS Documentation
- CAPA
- Deviation
- Change Control Handling
- In-process Quality Assurance (IPQA) (Sterile)
- GMP & Regulatory Audit Preparation
- Line Clearance
- Batch Monitoring
- MS Office
- Documentation Systems
Accomplishments
- Played key role in preparing QMS documentation for WHO-GMP & EU audit at Akums - praised for SOP compliance and document traceability.
- Actively supported data integrity training for new QA personnel, ensuring 100% understanding of ALCOA+ principles.
- Closed multiple deviations and CAPAs within timeline.
Projects
Mock Audit Preparation File, Compiled a document checklist and QA document structure as part of a self-study audit preparation for WHO-GMP inspection scenarios.
CAPA Tracker Template, Created a working Excel model to track Corrective and Preventive Actions (CAPAs) including assignment, due dates, follow-ups, and effectiveness check.
Media Fill Simulation Review, Compiled step-by-step process of a simulated media fill test, including gowning, filling, incubation, and result interpretation.
Hobbies and Interests
- Exploring pharmaceutical innovations and QMS case studies
- Meditation
- Gardening or nature walks
- Volunteering or community health awareness
Languages
- English, Full Professional Proficiency
- Hindi, Native or Bilingual Proficiency
- Punjabi, Full Professional Proficiency
Affiliations
• Volunteered in workplace-organized blood donation drives as part of corporate social responsibility initiatives. Jul. 2024
Timeline
Executive-QA
Shamshree Lifesciences Ltd.
04.2025 - Current
Asst. Executive-QA Documentation
Akums Pure And Cure Healthcare Pvt. Ltd
01.2024 - 03.2025
Officer- Production Chemist
Zee Laboratories Ltd
02.2021 - 12.2023
B. Pharmacy -
Lovely Professional University