Nazma Khan
Noida
Summary
Detail-oriented Quality Assurance professional in pharmaceutical and nutraceutical manufacturing, ensuring compliance with cGMP and WHO-GMP standards. Developed 120 SOPs, led deviation investigations, and managed change control and internal audits to strengthen regulatory adherence. Expertise in IPQA and batch record review drives impactful quality initiatives.
Overview
4
4
years of professional experience
Work History
Quality Assurance Coordinator
Steadfast Limited
Noida
02.2026 - Current
- Ensure compliance with current Good Manufacturing Practices (cGMP), WHO-GMP, Schedule M, FSSAI, and applicable regulatory requirements.
- Monitor manufacturing and packaging activities to ensure adherence to approved SOPs and GMP guidelines.
- Monitor line clearance before the start of manufacturing and packaging operations.
- Verify cleanliness and readiness of equipment, production areas, and utilities before batch initiation.
- Ensure personnel follow gowning, hygiene, and contamination control procedures.
- Reviewed and controlled 120+ Standard Operating Procedures (SOPs) for Pharmacovigilance (PV) and Environment, Health & Safety (EHS) departments, ensuring compliance with regulatory and organizational standards to support operational excellence.
- Developed and maintained a comprehensive regulatory registration and import license matrix for international markets, including Nigeria, Kenya, Ghana, United Arab Emirates (UAE), Saudi Arabia, and other export destinations.
- Verified and reviewed critical quality documents, including the Site Master File (SMF), ensuring compliance with WHO-GMP and regulatory expectations.
- Prepared WHO-recommended hand hygiene practices, including hand washing and hand rubbing (hand sanitization) procedures, across manufacturing and controlled areas.
- Coordinated cross-functional teams to maintain document control and change control, ensuring regulatory compliance for quality system documentation and improving audit readiness.
- Assisted in maintaining quality records and ensuring all controlled documents were current, approved, and readily available for audits and inspections.
- Review and monitor implementation of Corrective and Preventive Actions (CAPA).
- Support process validation, equipment qualification (IQ/OQ/PQ), and periodic revalidation activities.
- Encouraged ongoing quality enhancement initiatives across departments to improve processes. and GMP awareness across departments.
- Prepare, review, issue, revise, and control Standard Operating Procedures (SOPs).
- Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for completeness and accuracy.
- Review equipment logbooks, cleaning records, calibration records, and maintenance records..
- Verify completeness of batch documentation prior to QA release.
- Ensure traceability of all manufacturing and quality records.
- Review analytical reports, reference standards and Certificates of Analysis (COA) where applicable.
- Ensure compliance with data integrity requirements and document retention policies.
Administrative Coordinator
SS Innovations International Inc
12.2024 - 01.2026
- Coordinated complex scheduling, meeting logistics, and domestic/international travel for senior leadership and cross-functional teams to ensure timely and effective communication.
- Managed executive calendars, scheduling meetings and appointments and coordinating travel arrangements to optimize time.
- Streamlined executive communication by efficiently managing emails, phone calls, and scheduling appointments to enhance responsiveness.
- Streamlined administrative and operational workflows for engineering, clinical, sales, and R&D teams, enhancing interdepartmental collaboration and project alignment.
- Prepared meeting agendas to outline discussion topics and objectives., taking meeting minutes, and tracking action items.
- Created high-quality reports, technical presentations, and management correspondence to support executive decision-making.
- Acted as a key liaison with hospital partners, distributors, and internal service teams, enabling seamless collaboration and operational continuity.
- Monitored project timelines and provided administrative support for R&D and product development activities.
- Supported process optimization initiatives that enhanced administrative efficiency and contributed to organizational operational excellence.
- Supported project management efforts by tracking deadlines, maintaining documentation, and communicating progress updates to stakeholders.
- Ensured strict confidentiality and secure handling of sensitive patient, clinical, and medical device information.
Quality Assurance Assistant
Soft Medicaps Limited
01.2023 - 04.2024
- Monitor manufacturing and packaging activities to ensure adherence to approved SOPs and GMP guidelines.
- Conduct routine in-process quality assurance (IPQA) checks at critical manufacturing and packaging stages.
- Verify cleanliness and readiness of equipment, production areas, and utilities before batch initiation.
- Perform line clearance before the start of manufacturing and packaging operations.
- Monitored dispensing of raw materials to ensure accurate quantities across production processes: weighing, mixing, granulation, compression, encapsulation, coating, filling, labeling, and packaging.
- Conducted routine GMP inspections, identifying and addressing compliance gaps to uphold quality standards.
- Ensure compliance with data integrity principles (ALCOA+).
- Participate in quality risk assessments and implementation of risk mitigation measures.
- Supported internal, customer, and regulatory audits, ensuring timely resolution of audit observations.
- Monitored implementation of Corrective and Preventive Actions (CAPA), ensuring effective resolution of quality issues.
Administrative Coordinator
Crtd Technologies
06.2022 - 12.2022
- Optimized time management for the Managing Director by handling day-to-day tasks such as calendar management, phone calls, and email correspondence.
- Streamlined communication flow by managing correspondence and scheduling for the Managing Director to facilitate timely decision-making.
- Screened calls and emails and initiated actions to respond or direct messages for managers.
- Streamlined office operations by implementing efficient filing systems and managing executive calendars to support workflow.
- Coordinated meetings and events to foster interdepartmental communication and collaboration.
- Provided professional administrative support during board meetings, including agenda preparation and minute-taking duties.
- Organized special events and conferences, coordinating logistics from venue selection to attendee registration to ensure successful execution.
- Coordinated interviews and assisted with new hire orientations to support human resources initiatives.
- Served as liaison between departments to ensure effective communication across the organization.
Education
MBA - Finance and Marketing
Assam University Silchar
Assam01-2022
M.Sc. - Life science and Bioinformatics
Assam University Silchar
Assam01-2019
B.Sc. - Zoology
GuruCharan College Silchar
Silchar01-2017
Skills
- Quality assurance
- Regulatory compliance
- SOP development
- Regulatory documentation
- Audit preparation
- Documentation control
- Document control
- Documentation oversight
- Quality indicators
- Data interpretation
- Product evaluation
- Cross-functional collaboration
Personal Information
Languages
- English
- Hindi
- Bengali
- Pashto
Timeline
Quality Assurance Coordinator
Steadfast Limited
02.2026 - Current
Administrative Coordinator
SS Innovations International Inc
12.2024 - 01.2026
Quality Assurance Assistant
Soft Medicaps Limited
01.2023 - 04.2024
Administrative Coordinator
Crtd Technologies
06.2022 - 12.2022
MBA - Finance and Marketing
Assam University Silchar
M.Sc. - Life science and Bioinformatics
Assam University Silchar
B.Sc. - Zoology
GuruCharan College Silchar