Summary
Overview
Work History
Education
Skills
Interests
Primary Contact Number
Personal Information
Disclaimer
Areas Of Interest
Timeline
Generic

Nelija Dias

Quality Assurance-Qualification and Computerized System Validation
Marcela

Summary

Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.

Overview

11
11
years of professional experience
2015
2015
years of post-secondary education
4
4
Languages

Work History

Assistant Manager

Cipla
02.2024 - Current
  • Equipment qualification (URS, GXP Assessment, FDS, DQ, SAT, FAT, Risk Assessment, IQ, OQ , PQ)
  • Computerized system validation (CSV) related activities including review of URS, GXP assessment, Validation Plan, FS, CS/DS, FRA, DQSR, Risk assessment, RTM, IQ, OQ and PQ)
  • Temperature mapping of storage and processing area
  • Qualification and requalification of air handling units
  • Periodic Review and Periodic qualification of equipments
  • Backup and restoration validation of data.
  • Knowledge of WHO guidelines related to qualification.
  • Well versed with the knowledge of GAMP-5 , 21CFR Part11 and EU Annex 11
  • Professional Achievement: Received employee of the quarter award for the period July 2024 to September 2024.

Sr. Officer

FDC Ltd
03.2022 - 02.2024
  • Process validation
  • Packing validation
  • IPQA
  • Equipment Qualification and utilities routine validation i.e. compressed air system, HVAC and water system
  • Review of PLC validation protocols
  • Preparation of Validation master plan, Site Master File
  • Validation related QMS activities
  • Calibration certificates and daily EMS data review of Engineering
  • Professional Achievement: Received employee of the quarter award for the period April 2023 to June 2023.

Sr. Officer

Sunpharma India ltd
07.2020 - 03.2022
  • Preparation of protocol and support in execution of new equipment qualification and requalification of existing equipments
  • Preparation and execution of validation protocol of requalification of compressed air system, nitrogen gas, HVAC, LAF, RLAF, dynamic pass box etc
  • Preparation of protocol and as support to vendor during execution of temperature mapping of warehouse and storage areas
  • Preparation of protocol and execution of routine validation activities of equipments
  • Experience in handling of change controls, deviations and internal audits
  • Preparation and review of SOP’s related to validation activities
  • Communicating with different vendors for timely completion of validation activities
  • Preparation of validation master plan and review of calibration and preventive maintenance schedule
  • Experience in facility, utility, compressed air and water system routine validation

Jr. Officer

Indoco Remedies Ltd
03.2016 - 10.2017
  • Experience in handling of following instruments:
  • Infrared Spectrophotometer
  • UV visible spectrophotometer
  • PH meter
  • HPLC (Schimadzu and Agilent)
  • KF Autotitrator
  • Melting point apparatus
  • Metrohm potentiometer
  • Working standard qualification
  • Calibration of balance
  • Calibration of HPLC
  • Calibration of pH meter
  • Standardisation of Kfautotitrator
  • Knowledge of method development and validation

Research Associate

Unichem Laboratories Ltd
07.2014 - 11.2015
  • Experience in method development and method validation of API

Education

M.Pharm - Pharmaceutical Chemistry

PES's Rajaram and TarabaiBandekar College of Pharmacy
Ponda, Goa

B.Pharm - undefined

Goa College Of Pharmacy
Panaji, Goa

Higher Secondary Certificate Examination (H.S.C.) - Goa Board

GVM's Higher Secondary School
Ponda, Goa

Secondary School Certificate Examination (S.S.C.) - Goa Board

Skills

  • Time management proficiency

  • cross-functional teamwork

  • strong verbal and written communication

  • commitment to continuous learning

  • dedicated professional

  • approachable attitude

Operations management

Interests

Reading Novels
Internet surfing
listening to music

Primary Contact Number

9529085479

Personal Information

  • Date of Birth: 08/05/91
  • Nationality: Indian

Disclaimer

I hereby declare that, all statements made in this application are true, complete and correct to the best of my knowledge.

Areas Of Interest

  • Equipment and Utilities Qualification
  • Computerised system Validation

Timeline

Assistant Manager

Cipla
02.2024 - Current

Sr. Officer

FDC Ltd
03.2022 - 02.2024

Sr. Officer

Sunpharma India ltd
07.2020 - 03.2022

Jr. Officer

Indoco Remedies Ltd
03.2016 - 10.2017

Research Associate

Unichem Laboratories Ltd
07.2014 - 11.2015

B.Pharm - undefined

Goa College Of Pharmacy

Higher Secondary Certificate Examination (H.S.C.) - Goa Board

GVM's Higher Secondary School

Secondary School Certificate Examination (S.S.C.) - Goa Board

M.Pharm - Pharmaceutical Chemistry

PES's Rajaram and TarabaiBandekar College of Pharmacy

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Nelija DiasQuality Assurance-Qualification and Computerized System Validation