Summary
Overview
Work History
Education
Skills
Volunteer Experience
References
Languages
Timeline
Generic

CHINTAN PAREKH

Parsippany,NJ

Summary

I have gained knowledge and experience of cGMP in Pharmaceutical Industry in sterile and non-sterile products. I am seeking for position where I can utilize my skills and develop my career. Systematic professional with exceptional organizational, planning and multitasking abilities. Positive and upbeat with a team-oriented attitude. Detail-oriented Sterile Processing Technician with over two years of related experience. Excellent verbal and written communication skills with hardworking and diligent nature.

Overview

9
9
years of professional experience

Work History

QC MICROBIOLOGY/ASEPTIC TECHNICIAN

FERRING PHARMACEUTICAL
04.2022 - 03.2023
  • Work occasional overtime and weekends to support business needs
  • Knowledge of Aseptic technique, GLPs, GMPs, Use Microsoft Office applications such as Word, Excel, & Outlook Basic working knowledge of LIMS and EDMS systems
  • Follows established standard operating procedures, methods and GMPs to conduct analytical testing and LIMS reporting within set timelines
  • Demonstrates a basic understanding of technical concepts supporting methodology and systems in Material, Product Testing or Environmental Testing Identifies out of specification data and raises issues to management Is trained and proficient in operating the following basic laboratory instrumentation:
  • Balances, pH Meters, Ovens, Sonicators, Centrifuges etc
  • Performs environmental monitoring of process areas
  • Performs high purity water, clean steam, and compressed gas systems sampling.
  • Enhanced aseptic techniques by diligently adhering to standard operating procedures and maintaining cleanroom environments.
  • Reduced contamination risks by consistently monitoring and adjusting environmental controls in the aseptic processing area.
  • Supported quality control efforts through accurate documentation of batch records, equipment logs, and other essential data.
  • Contributed to successful audits through thorough preparation, timely responses to inquiries, and detailed recordkeeping.
  • Ensured product safety and efficacy by conducting routine inspections of final products for defects or deviations from specifications.
  • Prevented potential hazards by properly disposing of waste materials according to established protocols.
  • Safeguarded employee well-being through active participation in safety training programs and adherence to all safety guidelines.
  • Facilitated smooth operations during shift changes by effectively communicating relevant information to incoming technicians.
  • Assisted in the training and onboarding of new Aseptic Technicians, providing guidance on critical aspects of aseptic processing protocols.
  • Followed OSHA, FDA and AAMI guidelines related to sterilization in compliance with administrative regulations.
  • Verified and maintained proper documents and records for sterilization.
  • Recorded biologicals and test results.
  • Handled and disposed of sharps, biohazards and other hazardous materials in accordance with established protocols.

Environmental monitoring Technician (EM Tech)

FERRING
10.2021 - 04.2022
  • Perform all environmental monitoring tests required to monitor the controlled areas and support manufacturing operations under the supervision and guidance of Microbiology Laboratory management
  • Capable to demonstrate good aseptic technique and cleanroom behavior
  • Demonstrated and apply good gowning technique during certification, re-certification, and routine monitoring
  • Capable to understand the operation and application of all monitoring devices that are automated or manually operated in the department such as pipette, balance, and pH balance
  • Experience in monitoring all environmental parameters, such as viable and non-viable sampling, personnel sampling, and utilities following laboratory and company guidelines
  • Perform required sampling utilizing contact plates, settling plates, and particle counters
  • Perform environmental monitoring testing and water/steam/gas sampling and testing on scheduled days
  • Operate autoclave for routine sterilization of laboratory supplies and media
  • Perform sampling of raw materials
  • Perform bioburden testing on, raw materials, in-process products, and components
  • Experienced in working with Laboratory Information Management Systems (LIMS)
  • Enhanced equipment performance by conducting regular maintenance and troubleshooting tasks.
  • Reduced downtime for machines through proactive identification and resolution of technical issues.
  • Performed troubleshooting and diagnosis on malfunctioning equipment.
  • Maintained quality assurance and customer satisfaction objectives.

Production technician

IMPRIMISRX
03.2021 - 09.2021
  • Coordinate preparation of clean room and compounding supplies Ensure product and materials transport from warehouse to clean room as per SOP Perform regular cleaning of room and equipment and fill out appropriate documents for engineering evaluation such as preventative maintenance Assist in labeling and processing production materials Support the cleanrooms, formulations, ILP, and compounding areas wherever necessary Possess understanding of GDPs; cGMP, 503B guidelines and company ISO standards Open/close clean rooms, Formulation pods and ILP in accordance with work instructions Use aseptic practices in daily work to assure sterility, quality, and integrity of all preparations Aseptically prepare bulk formulations of non-sterile and sterile products as per formula batch records Perform bulk bag weighing using analytical scale; filter integrity testing Assist in calibration for analytical balance, air sampler, particle counter, filter integrity tester, pH meter Maintain Aseptic Gowning Qualification to support cleaning and aseptic filtration processing in ISO 7 & ISO 8 work spaces Communicate production management of deviations to established processes or procedures Maintain FEFO of chemicals used in preparations; Pull expired chemicals monthly Assist other areas as needed (cleaning; non-sterile filling; ILP; etc.)

Packaging Operator

AMNEAL PHARMACEUTICAL
04.2020 - 12.2020
  • Worked in cGMP environment in packaging area Responsible to ensure that each equipment machine is in good repair and works in accordance to regulations including regular and preventative maintenance/calibration Responsible for in process quality evaluation, batch reconciliation as per batch record (commercial/Submission) for different types of dosage forms (solid/Liquid etc) Assist in developing SOPs and handle reviews of batch records including quality investigations Familiar with regulation related to controlled substances Create daily reports regarding packaged products and storage and delivery orders

Packaging Operator

PAR PHARMACEUTICAL
12.2016 - 03.2020
  • Worked in cGMP environment for 3+ years in packaging and manufacturing area Handle startup and shut down duties pertaining to packaging equipment at the beginning and end of each shift for solid, liquid (solution/Suspension), topical and powder for oral suspension dosage forms Assist in developing SOPs and handle reviews of batch records including quality investigations Familiar with regulation related to controlled substances Train junior workers on exercising caution to avoid accidents and prevent injuries Maintain a clean and orderly work area by ensuring that floors are clean and organized appropriately Sort, label, grade and inspect packaged products Stack packaged items in storage areas or on delivery pallets using jack pallets or forklifts Create daily reports regarding packaged products and storage and delivery orders

Manufacturing Operator

PAR PHARMACEUTICAL
12.2016 - 03.2020
  • Worked in manufacturing area as required by department to assist commercial operations Worked on R&D scale up/submission batches as assistant to assigned R&D personnel for several solid and liquid dosage forms
  • Familiar with equipment such as Propeller mixer, High shear homogenizer, Granulation, milling and coating equipment including fluid bed coater Worked with R&D team to evaluate process feasibility and improvements

Receiving Manager

ALPINE HEALTH
11.2013 - 08.2016
  • Oversee receiving, warehousing, distribution and maintenance operations Work directly with clients, suppliers and transport companies Plan work schedules, trainings to new employees, assign tasks appropriately and appraise results Produce & maintain daily reports and statistics regularly (IN/OUT status report, dead stock report etc) Hands on experience with warehouse management software (i.e
  • NET SUITE)

Education

Bachelor of Commerce -

Sahajanand College
India
04.2000

Skills

  • Strong attention to detail
  • Quality Control Testing
  • Hazardous Materials Handling
  • Documentation and Recordkeeping
  • Cleanroom Protocol Expertise
  • Gowning and Gloving Competence
  • Environmental Monitoring Knowledge
  • Batch Production Records Management
  • Good Manufacturing Practices Compliance
  • Filter Integrity Testing
  • Standard Operating Procedures Adherence
  • Cross-Contamination Prevention
  • Sterilization Procedures Proficiency
  • Quality Control
  • Attention to Detail
  • Problem-solving abilities
  • Multitasking

Volunteer Experience

YOGI DIVINE SOCIETY, NONPROFIT ORGANIZATION, Youth leader in leading and directing various activities, 10/2010, current, Gaining experiences in various extra-curricular activates, Participating in youth development seminars held internationally in U.S., Canada, India, U.K., Africa, and Dubai, Main event Coordinator at Hindu Swaminarayan Temple at Parsippany, NJ, Organized and participated in health camps held at our various locations within NJ

References

Professional and Academic References Furnished Upon Request

Languages

English
Full Professional

Timeline

QC MICROBIOLOGY/ASEPTIC TECHNICIAN

FERRING PHARMACEUTICAL
04.2022 - 03.2023

Environmental monitoring Technician (EM Tech)

FERRING
10.2021 - 04.2022

Production technician

IMPRIMISRX
03.2021 - 09.2021

Packaging Operator

AMNEAL PHARMACEUTICAL
04.2020 - 12.2020

Packaging Operator

PAR PHARMACEUTICAL
12.2016 - 03.2020

Manufacturing Operator

PAR PHARMACEUTICAL
12.2016 - 03.2020

Receiving Manager

ALPINE HEALTH
11.2013 - 08.2016

Bachelor of Commerce -

Sahajanand College

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