SARITA MAHAJAN
MUMBAI
Summary
- I have research-oriented profession with 10 years of experience in Pharmaceutical research and development ,Quality Assurance and Clinical Research Organization. I am keen to achieve the goal for the organization in any challenging situation and am willing to work as a key player in a creative environment. Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Technical Consultant CSV
Fortrea Drug Development Company
PUNE
01.2023 - Current
- Responsible for Validation activity based on 21 CFR part 11, risk assessment & documentary as per guideline
- Preparation of validation Plan and Validation Summary Report
- Review of complete validation documents such as URS, FRS, IQ, OQ, PQ, TM, etc
- Working on Argus, Axway related Projects like Implementation and Upgradation for Clients
- IRMS Max system upgradation for all clients
- Participated in project planning meetings to discuss scope, timeline and budget.
- Analyzed customer data to identify trends or potential problems.
- Maintained accurate records of all technical activities performed for each customer.
- Improved services and technologies through continued analysis of system performance.
- Updated project manager twice weekly regarding status of open projects.
- Disaster Recovery Drill and Data Migration
- Working on Periodic review for Argus system for all Clients
- SOP related to IT-QA, CSV, Data backups, restoration, and Change control
- Participated in meeting with IT & validation team, in order to track project status & to verify the project status & to verify the project progress complies with the project schedule
- Initiation and closure of any deviations
- Ensure accuracy & completeness of test records.
Validation Project Lead
Harjai Computers
MUMBAI
04.2021 - 01.2023
- Responsible for Validation activity based on 21 CFR part 11, risk assessment & documentary as per guideline
- Preparation of validation Plan and Validation Summary Report
- Review of complete validation documents such as URS, FRS, IQ, OQ, PQ, TM, etc
- Working on Argus-related Projects like Implementation and Upgradation for Clients
- Disaster Recovery Drill and Data Migration
- Working on Periodic review for Argus system for all Clients
- SOP related to IT-QA, CSV, Data backups, restoration, and Change control
- Participated in meeting with IT & validation team, in order to track project status & to verify the project status & to verify the project progress complies with the project schedule.
Sr. Executive QA
Micro Labs Ltd
MUMBAI
12.2013 - 02.2021
- To conduct internal audits as per the schedule and ensure compliance with the observation
- Change Control Management through QMS
- To Review Deviation and Incident
- Review of Finished Product Specifications and API Specification
- Review of Formulation and Analytical documents
- Review of Product Development Report
- Preparation, Review & implementation of SOPs, and update as required
- Review of Analytical Method Validation Protocol and Report
- Review of Query Related data received from US and EU authorities
- Review of Justification related to analytical and formulation
- Review of calibration schedule of Instruments/Equipment
- To perform Quality Assurance rounds
- Interacts professionally with company management, internal departments, and other sites to effectively implement and maintain Quality Systems
- Execution of IQ/OQ/PQ activity of equipment and documentation (URS, IQ, OQ, PQ) of Dissolution (Electro lab, Sotax), UV (LabSolutions), HPLC (Empower), Stability Chamber (Newtronic)
- Having Knowledge of Caliber LIMS Software and as role of reviewer for Approval
- Reviewing the calibration Reports, Standard and Column usage through LIMS
- Implementation of DMS Caliber Software for SOP
- Handling of Computer System Validation activity related to: UV Probe Software for UV Spectrophotometer, Lab Solution Software for UV Spectrophotometer Empower Software for WATERS HPLC
- Chromeleon Software for Agilent and Dionex
Education
PG Diploma in Regulatory Affairs(API & Formulation) - Regulatory Affairs
Institute of Pharmaceutical Management
Vashi (Maharashtra)09.2018
Master in Pharmacy - Medicinal And Pharmaceutical Chemistry
MET’s Institute of Pharmacy, Bhujbal KnowledgeCity
Nashik(Maharashtra)05.2012
B.Pharmacy - Pharmacy
Women’s College of Pharmacy,(SNDT University)
Chincholi(Maharashtra)04.2010
Diploma in Pharmacy - Pharmacy
Tapivali Education Society Institute of Pharmacy
Faizpur (Maharashtra)04.2003
High Secondary School Certificate (12th) - Science Education
Seva Sadan English Medium School
Burhanpur (M.P)05.2001
Higher Secondary School (10th) - Science
Seva Sadan English Medium School
Burhanpur ,(M.P)05.1999
Skills
- Project Management
- Computer System Specialist
- Project Planning
- Change Management
- Technical Consulting
- Quality Assurance Specialist
- Supple and Self-motivated
- Ability to think logically and proactive
- Ability to work as part of a team and on own initiative in a constructive manner
Area of Interest
- Computer System Specialist
- Quality Assurance
- CRO
- R & D Pharma
Personal Details
- Name : Sarita Vilas Mahajan
- Date of Birth : 13th April 1983
- Place of Birth : Burhanpur
- Marital Status : Married
- Nationality : Indian
Languages
English
First Language
Hindi
Intermediate (B1)
B1
Marathi
Intermediate (B1)
B1
Certification
- Diploma In Pharmacy License
Timeline
Technical Consultant CSV
Fortrea Drug Development Company
01.2023 - Current
Validation Project Lead
Harjai Computers
04.2021 - 01.2023
Sr. Executive QA
Micro Labs Ltd
12.2013 - 02.2021
PG Diploma in Regulatory Affairs(API & Formulation) - Regulatory Affairs
Institute of Pharmaceutical Management
Master in Pharmacy - Medicinal And Pharmaceutical Chemistry
MET’s Institute of Pharmacy, Bhujbal KnowledgeCity
B.Pharmacy - Pharmacy
Women’s College of Pharmacy,(SNDT University)
Diploma in Pharmacy - Pharmacy
Tapivali Education Society Institute of Pharmacy
High Secondary School Certificate (12th) - Science Education
Seva Sadan English Medium School
Higher Secondary School (10th) - Science
Seva Sadan English Medium School
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