ANUJA RANJAN

ad1vi6@r.postjobfree.com

609-***-****

USPL Nutritional LLC, North Brunswick, NJ April 2021 to October 2022

Quality Assurance Documentation Specialist

Preparation and review of finished product specification & COA format.

Review and approve COA of finished product and external lab result of finished product.

Reviewing the BOM, Customer Specification and Formula card.

Identify non-compliance and propose the effective solution.

Managing all Customer specification and In-house specification.

Detailed knowledge of SOP and 21 CFR 111 and 117.

Assist in customer complaint and investigation.

Archive and revise outdated documents and ensure that the correct version is in use

Opening and Completion of Change control for product specification related.

Work with internal teams to obtain an in-depth understanding of the processes and documentation requirements

PIM Brand LLC, Somerset, NJ July 2020 to March 2021

Quality Control Inspector

Inspect all incoming material including Raw material, Packaging materials and R&D Materials (21 CFR 111)

Reviewing the label of Welch’s candy’s pouches and boxes for nutritional value.

Verify the certificate of analysis and FDA documents for imported materials.

Approve or reject the incoming candies and packaging material in M3 system.

To supervise packaging room to assure packaging is done according to SOP.

Perform metal detector test to assure its proper function.

Record Temperature and relative humidity of the packaging room.

Give the line clearance for production.

Perform sensory evaluation of candies.

Bioactive Resources LLC. South Plainfield, NJ January 2019 – March 2020

Quality Control Coordinator

Responsible for creating regulatory statements for raw materials, Non-GMO statements, Organic certified, Kosher certified etc.

Reviewing vendor qualification documents, vendor’s regulatory documents and COA for incoming raw material and cGMP documents.

Initiating the investigations, and assist in the root cause analysis and Preparation of investigation report for manufacturing unit.

Assigning lot numbers, filing change controls, CAPA and SARF.

Preparation, review and release the batch manufacturing record (BMR).

Responsible for preparing COA of finished products & laboratory scale pre-blends for each manufacturing batch.

Performing weekly GMP walk, environmental monitoring and maintain EMP reports (21 CFR 111 and 117)

To perform microbial testing on raw material through M3 system.

Testing of cleaning and sanitizing agents (Chem station) and RO water.

FTIR and micro testing using 3M technology.

Qtech Solution Inc, East Windsor, NJ December 2020 - February 2021

Clinical Research Associate- In House Training

Technical learning:

Extensive knowledge pertaining to all phases of clinical trials in different therapeutic areas such as Oncology, Central Nervous system and cardiology in accordance with the applicable ICH, GCP, FDA and local regulation

Remarkable Knowledge in all areas of research including budgeting, GCP, IRB protocol submissions, on-going regulatory and IRB phases and IND safety reporting.

Demonstrated competencies in managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.

Developed and authored Case report Forms (CRFs)

Created and Reviewed Informed consent forms

Detailed knowledge of study specific regulatory documents and able to update, and maintain study specific trial master files and system.

Knowledge of adverse events and serious adverse events reporting to the regulatory authority and FDA according to the GCP guidelines

Anagha Pharma Private Limited, India July 2009 - June 2010

Pharmacist

Provide information to customer regarding dosage, drug interaction, side effects and proper medication storage to prevent harmful interaction

Responsible for analyzing prescribed trend to monitor patient complaints.

Order Purchase pharmaceutical supplies, medical supplies.

Education:

Master’s in science (Pharmacology) July 2015 -June 2017

Rajiv Gandhi University of Health Science, Bengaluru, Karnataka, India

Bachelor in Science (Pharmacy) Sept 2004-Sept 2008

Rajiv Gandhi University of Health Science, Bengaluru, Karnataka, India

Topic of Dissertation

To evaluate the potential benefits of Tephrosia purpurea in Anemia and Thrombocytopenia.

Anemia is induced by IP injection of phenyl hydrazine in Sprague Dawley rats, and then treated with methanaloic extract of T. Purpurea orally for 14 days and then various parameter Hemoglobin, RBCs, and MCH is evaluated.

Publications

Effect of Anemia on Cognitive functions. Journal of Pharmaceutical Research. 2017; 16(2):134-142.

An Overview on Anxiety: Etiology and Therapy. Journal of Pharmaceutical Research. 2017; 16(1):32-37

Industrial Training March 2008 - April 2008

Completed 150 hours of industrial training at Karnataka Antibiotics Pharmaceuticals Ltd.

Certificates

Excel for Business Level -Intermediate

November-2021

Clinical Research Associate- In House Training

Qtech Solution Inc, Somerset, NJ

Dec 2020-Jan 2021

NIDA Clinical Trial Network Certification online

December 2020

FSPCA Certificate (PCQI)

April 2019

Bio Informatics Software (SAS)- base programming 9.0

March 2018

Certificate course in clinical research and development

January 2017

Certificate course in pharmaceutical regulatory affairs

January 2016

Skills:

Thoroughly trained on 21 CFR part 111, 21 CFR part 117, cGMP, FSMA, HACCP and SOP

Clinical trial phases, ICH, CGCP, FDA, NDA and local regulation

MS Office (Word, Excel, Power Point), Microsoft 365 and SharePoint

Windows Operating System & Outlook

Very good team and time management skill and work in busy environment.

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