Nidhi Sachan
Assistant Manager
Summary
A proactive approach to problem-solving and collaboration enables adaptability and thriving in dynamic environments. A passion for continuous learning and improvement aligns with the goals of forward-thinking organizations. Proactive and meticulous Assistant Manager with over 6 years of experience in Pharmaceutical and Medical Devices industry. Proficiencies in QMS, Audit and Compliance and staff training and development. Customer-oriented team player with expertise generating optimal satisfaction levels while building profits and client generation.
Overview
6
6
years of professional experience
2
2
Certification
Work History
Assistant Manager
Becton Dickinson (BD INDIA)
12.2022 - 12.2025
- Oversee country complaint management for India and Greater Asia.
- Managed reporting of adverse events and field actions.
- Oversaw distribution quality functions (QMS, Global hold, Local hold, labeling)
- Document Coordinator for India/SA.
Technical Regulatory Expert
Rihim Pharma Consultancy
06.2022 - 12.2022
- To compile and present dossier for products provided to licensing partners
- Conformity with raised queries from parties.
- Coordinate and file online application for BA/BE, CT 10, 16, 21, form 40, to DCGI on SUGAM portal.
- Executed thorough review of dossier created by two teammates and analyzed gaps within said document.
- Supports creation of product development documentation, including gap analyses and clinical development strategies.
- Supports preparation of regulatory submission documents, including components of INDs, NDAs, MAAs, DMFs, variations, renewals, MATs, and other lifecycle maintenance activities in compliance with current government regulations and guidelines.
- Executes regulatory research aimed at identifying regulatory precedents and assisting in preparation of orphan drug designation requests.
- Executes quality assessments on associated documents.
- Supports preparation of regulatory submissions and performs necessary regulatory investigations.
- Aids clients and customers in accessing general information
- Assembles, synthesizes, assesses, and conveys information.
- Assembles information, investigates files and records, and engages in personal outreach to secure specific information for comprehensive report development and routine correspondence drafting.
- compliance with regulations
Assistant Executive in Quality Assurance and Regulatory Affairs department
Akums Drugs and Pharmaceutical
06.2019 - 06.2022
- Worked in various sub department like Investigation QA (June 2019 - December 2019)
- Part of the investigation team in the Oral Solid dosage form facility (125 Cr. unit output in a month)
- Responsible for the compliance of the shop floor issues in coordination with senior management (Plant head, QA head, Block Head and user department HOD)
- Review the work pattern of IPQA/production and raise the non compliance issues.
- Quality Management System (November 2019 - October 2020)
- DEVIATION
- INCIDENT
- CHANGE CONTROL
- CAPA
- MARKET COMPLAINT
- AUDIT AND COMPLIANCE
- VENDOR QUALIFICATION
- Handling of the deviation, incident, change control, CAPA, Market complaint and audit and compliance of the oral solid dosage form facility.
- Lead the team of 7 officers and holded the responsibility of handling of change control, deviation, incident, CAPA, Change control, Market complaint, Audit and compliance and CAPA. Ensure the timely procedure of all the activity from initiation to closure in Amplelogic software for aforesaid activity.
- Investigated the incident, deviation, market complaint with proper channel of RCA tool in coordination with one junior and established the root cause/CAPA as required.
- Audit & Compliance (November 2020 - March 2021)
- Played the role of scribber in the Audit with various leading client of Akums Drugs and Pharmaceutical limited i.e. Cipla Limited, Abbott Healthcare Pvt. Ltd., Mylan, Merck, UCB etc.
- Ensure the compliance of the critical points in three days and major points in seven days with send the report to the respective client with necessary documents
- Arrange the internal Audit as per SOP and ensure the compliance of the same.
- Handling of Market Complaint and Reported Adverse Drug Reactions (April 2021 - till date)
- Responsible for revert of the received market complaint within given time line period as per SOP with necessary documents and investigation report.
- To register the CAPA (if required)
- Ensure the compliance of the root cause and registered CAPA at the shop floor.
- Responsible to send the Addendum report in case of received compliant sample, closure report and CAPA effectiveness report as per investigation.
- Regulatory compliance
Education
M. Pharmacy - Pharmaceutics
Galgotias University
Greater Noida01.2019
B. Pharmacy - Pharmacy
Babu Banarsi Das University
Lucknow01.2017
Senior Secondary - Science
Takshashila Public School
Shahjahanpur01.2013
Matriculation - General
Dr. Virendra Swaroop Education Centre
Kanpur01.2011
Skills
Proffesional Skills:
Interests
Travelling, Reading fiction novel, Writing quotes, Dancing, Listening music
Accomplishments
- Review and Research Paper
- Review Paper 1 Recent Advances and Novel Approaches for Nose to Brain Drug Delivery
- For Treatment of Migraine- Published
- Review Paper 2: Nanoparticle System: Promising Approach for the Management of Alzheimer’s
- Disease through Intranasal Delivery- Published
- Review paper 3: Rheumatoid Arthritis
- Research paper 1: Formulation and Development of Quercetin Loaded Chitosan Nanoparticle via Ionic Gelation Method for Nasal Drug Delivery- Communicated
- Patent 1: Nasal Nano particulate gel for the treatment of Alzheimer Disease.; Under Process
- Cracked the campus job interview in competition with Jamia Hamdard Students and perused the interest instead of opting the money.
- 1st Prize in Poster Presentation on the topic “Female Foeticide” (2013).
- 1st prize on oral presentation on the topic entitled “Recent Advancement in Alzheimer Disease” (2016)
- 2nd position on poster presentation on the topic entitled “ Drug Discovery” (2016)
Publications
- Research paper Published on Nanoparticlized System: Promising Approach for the Management of Alzheimer’s Disease through Intranasal Delivery
- Recent Advances and Novel Approaches for Nose to Brain Drug Delivery for Treatment of Migraine
- Attended International Conference on the topic “Cancer” at BBAU, (2017)
- Attended Conference on “Frontiers in Nanotechnology” at Galgotias University, (2018)
- Attended International Conference organized by DCM edutech, (2018)
Disclaimer
I hereby declare that all the information furnished by me is true to best of my knowledge.
Certification
Https://doi.org/10.2174/2210303109666190508083142
Timeline
Assistant Manager
Becton Dickinson (BD INDIA)
12.2022 - 12.2025
Technical Regulatory Expert
Rihim Pharma Consultancy
06.2022 - 12.2022
Https://doi.org/10.2174/2210303109666190508083142
09-2019
Assistant Executive in Quality Assurance and Regulatory Affairs department
Akums Drugs and Pharmaceutical
06.2019 - 06.2022
M. Pharmacy - Pharmaceutics
Galgotias University
B. Pharmacy - Pharmacy
Babu Banarsi Das University
Senior Secondary - Science
Takshashila Public School
Matriculation - General
Dr. Virendra Swaroop Education Centre