Summary
Overview
Work History
Education
Skills
Certification
Equipment Knowledge for PM/CAL.
Timeline
Generic

NAZIM RENTIA

Iselin,NJ

Summary

Dynamic Senior Chemist with extensive experience at Cosette Pharmaceuticals, excelling in instrument calibration and regulatory compliance. Proven track record in developing SOPs and managing change controls, ensuring quality assurance. Adept at troubleshooting complex laboratory equipment while fostering a culture of safety and continuous improvement. Proficient in Empower-3 and Qumas documentation systems.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Metrology /Senior Chemist

Cosette Pharmaceuticals
South Plainfield, NJ
04.2020 - 06.2024
  • Led preventive maintenance and calibration of analytical laboratory instruments and Bioequivalence laboratory.
  • Developed and executed installation, operational, and performance qualification protocols for new equipment or relocated instruments in collaboration with vendors.
  • Maintained computerized maintenance management system software for scheduling calibration/PM, tracking, and logging calibration data for laboratory instruments.
  • Managed change controls, deviation, and instrument repair reports, along with investigation reports.
  • New drafted, reviewed SOPs, and equipment logbook updates were coordinated through the QUMAS documents control system.
  • Ensured regulatory compliance with FDA, cGMP, GLP, performing regular audits, and corrective actions. Participated in internal and external audits, and supported audit readiness for laboratory and equipment.
  • Verified analytical balances daily, and recorded weight verification logs. Daily monitored temperature and humidity for laboratory rooms, freezers (-80°C and -25°C), stability chambers, and refrigerators; conducted root cause analysis for excursions.
  • Preventive maintenance, troubleshooting, repair, investigation, and calibration/qualification of almost all sophisticated laboratory instruments, such as HPLC, UHPLC, GC, dissolution apparatus, TOC, Milli-Q water system, KF titrator, pH meter, melting point, viscometer, rheometer, vacuum oven, regular oven, Franz diffusion cell equipment, particle size instruments, analytical balance, etc.
  • Developed training programs for lab personnel on proper use of metrology instrumentation.
  • Provided technical support to other departments regarding quality control issues related to metrology operations.
  • Evaluated new technologies that could be used to improve metrology processes.
  • Supervised installation, repair or modification activities related to metrology instrumentation.
  • Provided technical guidance to lab staff on metrology principles and practices.
  • Performed preventative maintenance on metrology equipment to ensure accurate operation. Created reports summarizing the results of metrology activities for management review.

Metrology

Aurolife pharma LLC, (Aurobindo pharma)
Dayton, NJ
08.2017 - 04.2020
  • Performed scheduled and executed preventive maintenance, and calibration/qualification for all major equipment using vendor-supported and internal programs.
  • Initiated change control, RRF documentation, when instrumentation calibrations indicated out of tolerance or failure.
  • Authored and reviewed analytical methods, validation protocols, and technical reports; managed logbooks and change records; ensured all documents are aligned with SOPs and regulatory standards.
  • Record data and results as specified in the documentation procedure. Documents work clearly, and perform tests accurately. Comply with all regulatory, in-house requirements (safety, cleaning, laboratory chemical waste, cGMP, CGLP documents) when performing the assigned activity.
  • Coordinated outside vendor services such as contract calibration and testing services when needed.
  • Troubleshooting, investigations, preventive maintenance, and calibration are almost all part of quality control in the lab. Instruments, such as analytical balances, UV-visible spectrometers, HPLC, U-HPLC, GC, dissolution apparatus, TOC analyzers, pH meters, melting point apparatus, viscometers, Milli-Q water systems, FTIR, etc.
  • Performed assigned sampling, physical and chemical tests, and assays on raw materials, active ingredients, in-process products, finished products, and stability products, using wet chemicals, physical techniques, and instrumental techniques as per pharmacopoeia monographs and any other compendial monographs.

Senior Executive /Senior Quality Control Analyst

S Kant Healthcare Ltd. (Cipla Ltd. & Pfizer Ltd.)
Vapi, Gujarat
03.2007 - 03.2016
  • Developed and maintained quality control documentation and standard operating procedures.
  • Monitored equipment calibration and maintenance to ensure optimal testing conditions.
  • Ensured that all required documentation is completed accurately and timely.
  • Maintained records of inspection results using appropriate software applications.
  • Identified quality problems and recommended solutions.
  • Performed audits of production processes to ensure compliance with quality standards.
  • Received and inspected raw materials.
  • Calibrated, validated or maintained laboratory equipment.
  • Maintained lab cleanliness and safety standards.
  • Monitored testing procedures to meet established item specifications, standard test methods or protocols.
  • Completed data capture forms, equipment logbooks or inventory forms to support testing procedures.
  • Preparation and standardization of volumetric solutions, bench reagents, buffer solutions, and indicators, ensure the inventory of laboratory chemicals, standards, and glassware.
  • Analysis of raw material and finished product. (Active ingredient, excipient, flavors, etc., and tablet, capsules, liquid, ointment, cream, and dry suspension.)

Education

Bachelor of Science - Pharmaceutical Chemistry

Veer Narmad South Gujarat University, INDIA
SURAT
04-2004

Some College (No Degree) - Data Entry Operator

Directorate of Employment And Training. INDIA
Gandhinagar, GUJARAT

Skills

  • Analytical techniques
  • Instrument calibration
  • Regulatory compliance
  • Quality assurance
  • Preventive maintenance, qualification, and repair: HPLC, U-HPLC, GC, dissolution, TOC, UV, FTIR, freezers, refrigerator, stability chamber, pH meter, balances, fume hoods, bio hoods, viscometer, rheometer, FDC, and particle sizer Mili-Q Waters system
  • Change management
  • Equipment troubleshooting
  • Laboratory safety
  • Software: Empower-3, ProCal, Trackwise, Qumas, LIMS, Pharma Suite ERP, Microsoft Office
  • Documentation: SOPs, BMR/BPR, STP, IQOQPQ protocol, logbooks, OOS, CAPA Change Control
  • Regulatory: cGMP, cGLP, ICH guidelines, FDA, WHO audit compliance

Certification

  • Technical person Approval, FDA- Gujarat, INDIA.

Authorized for chemical & physiochemical testing under Drugs & Cosmetics Act. 1940.

Equipment Knowledge for PM/CAL.

  • HPLC : Waters 2695, Waters Aquity UHPLC, Agilent HPLC 11 & 12 series, Shimadzu LC 2010, LC 2030CHT, Agilent GC 6890, Agilent 7890, Agilent Dissolution, Distek Dissolution, Logan Dissolution, Logan FDC, PermeGear FDC, Brookfield Rheometer, Malvern Mastersinger 3000, TA rheometer, Shimadzu AAS, Metrohm KF, Mettler Toledo balance, Thermo fischer FTIR, TA DSC, pH meter, Oven, Refrigerator, Freezers, Stability Chambers, TOC SUEZ, Mille Glassware Cleaning Equipmet,

Timeline

Metrology /Senior Chemist

Cosette Pharmaceuticals
04.2020 - 06.2024

Metrology

Aurolife pharma LLC, (Aurobindo pharma)
08.2017 - 04.2020

Senior Executive /Senior Quality Control Analyst

S Kant Healthcare Ltd. (Cipla Ltd. & Pfizer Ltd.)
03.2007 - 03.2016

Bachelor of Science - Pharmaceutical Chemistry

Veer Narmad South Gujarat University, INDIA

Some College (No Degree) - Data Entry Operator

Directorate of Employment And Training. INDIA

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