To begin my career in a high-level professional environment that secures a responsible career opportunity to fully utilize my training and skills, while making a significant contribution to the success of the company.
Hi, I’m
Divya Kancherla
Plainfield,IN
Summary
Overview
12
years of professional experience
1
Certification
Work History
Novartis RLT, Indianapolis
QA Batch release Specialist
03.2025 - Current
Job overview
- Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity.
- Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
- Controlled issuance of batch records in preparation for manufacturing.
- Assist functional areas with achieving timely and compliant final product disposition of the product.
- Assisted functional areas in achieving timely and compliant final product disposition.
- Supported tracking of documentation and release data to facilitate continuous improvement.
- Supported QA batch release by collaborating with cross-functional teams to enhance safety and quality standards.
- Ensure timely escalation to management of all applicable incidents.
AAA, a Novartis company (Millburn, NJ)
Quality Assurance Operations Specialist
03.2024 - 03.2025
Job overview
- Ensure quality and compliance with our products and processes.
- Conduct quality assurance activities by implementing quality control measures, performing audits and inspections, and identifying and resolving quality-related issues.
- Ensure all products and processes meet regulatory requirements and industry standards.
- Establish and maintain quality standards for all pharmaceutical operations, including manufacturing, packaging, and distribution.
- Collaborate with cross-functional teams, such as production, research and development, and regulatory affairs, to ensure quality and compliance across all company areas.
- Conduct training and education on quality standards, procedures, and regulations to ensure that all staff are knowledgeable and compliant.
- Identify and implement process improvements in processes and procedures by implementing changes to increase efficiency and quality.
- Perform risk assessments to identify potential quality and compliance issues and develop strategies to mitigate any risks.
- Maintain documentation and records for accurate and detailed records of all quality assurance activities, including audits, inspections, and corrective actions taken.
LIPTIS PHARMACEUTICALS USA INC
Quality Assurance senior specialist
01.2022 - 03.2024
Job overview
- Evaluate and approve all documents according to organization regulations and maintain knowledge on all awareness issues and recommend strategies to management.
- Perform quality audit on all systems internally to prepare reports for all issues in packaging areas and review all technical issues and recommend solutions for same.
- Evaluate all packaging and manufacturing dates for all batches and ensure compliance with all safety measures in areas.
- Collaborate with the production team to monitor all work according to required quality system and evaluate all standard operating procedures and execute all compliance systems to ensure effectiveness of all programs.
- Perform assessment of all company standards and implement all quality systems on same and develop corrective actions to eliminate all issues from quality system and design all procedures for organizations compliance system.
- Updated production records, evaluated procedures, and monitored compliance with new organizational regulations.
- Investigate all impact of procedures on quality assurance activities and ensure compliance to all time frames and process all operations and perform tests on all releases and prepare efficient time frame to achieve all company objectives.
- Provide support to all manufacturing operations and implement it efficiently and supervise all activities and administer all Quality Assurance systems and evaluate all batch records and perform audits on same and ensure compliance to all quality systems.
- Experience in writing SOPs, as well as reviewing the department’s SOPs.
- Performed root cause analysis to identify underlying issues.
- Experience in performing mock recalls to check the traceability.
- Performed internal audits efficiently to ensure compliance with quality standards.
- Ensure that the product labeling is as per the regulatory requirements in various markets.
- Prepare all the product related documents for registration process in various middle east markets.
- Participated in the external audits (FDA and third-party)
MSN PHARMACEUTICALS INC
API-Sales Specialist
10.2019 - 12.2021
Job overview
- Analyze customer base to identify and develop new opportunities and re-evaluate existing opportunities.
- Executed commercial and developmental purchase orders and agreements with assigned accounts.
- Assist with the preparation of Annual Reports by coordinating documentation with regulatory team offshore and sending the change notifications to the clients who filed for ANDA.
- Provided documents to QC for review to ensure adherence to submission requirements.
- Assist with the compilation of documents necessary to RA team for submissions by providing support and appropriate document uploading into established submission format (eCTD).
- Manage defined accounts with back-office customer service, marketing, finance, and logistical support
- Develop in-depth knowledge of the product line, understanding the needs of this group of customers, the competitive landscape and knowing how to sell MSN’s API products based on their requirements.
- Evaluate, validate, and identify potential CMO’s for API manufacturing.
- Facilitated communication between regulatory team and clients regarding ANDA-related queries.
- Provide monthly forecast for production planning.
- Coordinated with offshore team to establish manufacturing and delivery schedules.
- Coordinate with API sales in accounts receivables reconciliation
CVS SPECIALTY PHARMACY, NY
Pharmacy Technician
05.2019 - 10.2019
Job overview
- Received written prescription or refill requests, verifying completeness and accuracy to ensure proper medication dispensing. Maintain proper storage and security conditions for drugs.
- Answer telephones, responding to questions or requests.Process the electronic, written prescription orders.
- The prior authorization for the prescription cannot be processed through insurance.
- Establish or maintain patient profiles, including lists of medications taken by individual patients.Prepack bulk medicines, fill bottles with prescribed medications, and type and affix labels.
- Mix pharmaceutical preparations, according to written prescriptions.
- Assisted customers by answering inquiries, locating items, and referring to pharmacist for detailed medication information.
- Receive and store incoming supplies, verify quantities against invoices, check for outdated medications in current inventory, and inform supervisors of stock needs and shortages.
- Order, label, and count stock of medications, chemicals, or supplies and enter inventory data into computer.
- Prepared and processed medical insurance claim forms and records to facilitate timely reimbursement for prescription services.
AMSTERDAM PHARMACY AND SURGICAL SUPPLIES, NY, NY
Pharmacy Technician
10.2016 - 12.2018
Job overview
- Received written prescription or refill requests, verifying completeness and accuracy to ensure safe medication dispensing. Maintain proper storage and security conditions for drugs.
- Answered telephone calls, providing accurate information and assistance to customers regarding their inquiries.
- Establish or maintain patient profiles, including lists of medications taken by individual patients.Prepack bulk medicines, fill bottles with prescribed medications, and type and affix labels.
- Mix pharmaceutical preparations, according to written prescriptions.
- Cleaned and maintained laboratory equipment and work areas, ensuring adherence to prescribed sterilization methods.
- Assisted customers by answering inquiries, locating items, and referring them to the pharmacist for comprehensive medication information.
- Receive and store incoming supplies, verify quantities against invoices, check for outdated medications in current inventory, and inform supervisors of stock needs and shortages.
- Order, label, and count stock of medications, chemicals, or supplies and enter inventory data into computer.
- Operate cash registers to accept payment from customers. Prepare and process medical insurance claim forms and records. Maintain and merchandise home healthcare products or services.
MISHKIN PHARMACY, NY, NY
Pharmacy Technician
07.2016 - 10.2016
Job overview
- Receive written prescription or refill requests and verify that information is complete and accurate.
- Established and maintained patient profiles, ensuring accurate medication histories for individualized care.
- Maintain proper storage and security conditions for drugs.Answer telephones, responding to questions or requests.
- Prepack bulk medicines, fill bottles with prescribed medications, and type and affix labels.Price and file prescriptions that have been filled.
- Cleaned work areas to maintain hygiene standards. and help maintain equipment or work areas and sterilize glassware, according to prescribed methods.
- Mix pharmaceutical preparations, according to written prescriptions.
- Ordered, labeled, and counted stock of medications and supplies, entering inventory data to support efficient pharmacy operations.
- Receive and store incoming supplies, verify quantities against invoices, check for outdated medications in currentinventory, and inform supervisors of stock needs and shortages.
- Assisted customers by answering inquiries, locating items, and referring them to the pharmacist for comprehensive medication guidance.
WALGREENS PHARMACY, EL DORADO HILLS, CA
Pharmacy Technician Intern
02.2016 - 02.2016
Job overview
- Receive written prescription or refill requests and verify that information is complete and accurate. Establish or maintain patient profiles, including lists of medications taken by individual patients. Maintain proper storage and security conditions for drugs.
- Answered telephone inquiries, addressing questions and requests to support customer needs.
- Clean and help maintain equipment or work areas and sterilize glassware, according to prescribed methods.Price and file prescriptions that have been filled.
- Receive and store incoming supplies, verify quantities against invoices, check for outdated medications in currentinventory, and inform supervisors of stock needs and shortages.
- Assist customers by answering simple questions, locating items, or referring them to the pharmacist for medication information.
- Received and stored incoming supplies, verified quantities against invoices, checked for outdated medications, and notified supervisors of stock shortages to ensure inventory accuracy.
M S RAMAIAH HOSPITALS, BENGALURU, KARNATAKA, INDIA
Clinical Pharmacist Intern
10.2014 - 10.2015
Job overview
- Reviewed prescriptions for accuracy and evaluated suitability.
- Collaborate with other health care professionals to plan, monitor, review, or evaluate the quality or effectiveness of drugs or drug regimens, providing advice on drug applications or characteristics. Analyzeprescribing trends to monitor patient compliance and to prevent excessive usage or harmful interactions.
- Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability.
- Provide information and advice regarding drug interactions, side effects, dosage, and proper medicationstorage.
- Collaborated with health care professionals to plan and evaluate drug regimens, offering insights on drug applications to optimize patient outcomes. Analyzeprescribing trends to monitor patient compliance and to prevent excessive usage or harmful interactions.
- Offer health promotion and prevention activities, for example, training people to use devices such as bloodpressure or diabetes monitors.
- Publish educational information for other pharmacists, doctors, or patients.
Education
M S RAMAIAH COLLEGE OF PHARMACYBENGALURU, KARNATAKA, INDIA
Doctor of Pharmacy from Pharm D
04-2016
University Overview
- Published an article in the International Journal of recent scientific research- A PROSPECTIVE STUDY ON ANTIBIOTICS PRESCRIBING PATTERN AND MEDICATION ERROR ON RESPIRATORY TRACT INFECTIONS IN ENT, CHEST MEDICINE AND GENERAL MEDICINE DEPARTMENT IN INDIA.
- GPA: 3.4
CALIFORNIA STATE UNIVERSITYCHICO, CA
Pharmacy Technician Course from Pharmacy
03-2016
University Overview
GPA: 4.0
Skills
- MS Office: Word, Excel, Power point and Outlook, One note
- Pharmacovigilance, Clinical study designs, Clinical Trials, Drug development, 21 CFR 210 and211, HACCP, 3AGestTwo, ConDor, LIMS, D365, ESOPS
- Incident management
- cGMP compliance
- Teamwork and collaboration
- Attention to detail
- Decision-making
- Detail-oriented
- Problem-solving abilities
- Reliability
- Excellent communication
- Task prioritization
Accomplishments
Accomplishments
- Author of “A PROSPECTIVE STUDY ON ANTIBIOTICS PRESCRIBING PATTERN AND MEDICATION ERROR ON RESPIRATORY TRACT INFECTIONS IN ENT, CHEST MEDICINE AND GENERAL MEDICINE DEPARTMENT IN INDIA,” published in International Journal of recent scientific research in 2015.
Certification
- Licensed Pharmacist in India
- Professional Certification in Pharmacovigilance from Catalyst Clinical Services Pvt. Ltd., New Delhi inOctober 2014.
- Drug Development Certificate from the University of San Diego
- GMP Certification
- FPGEC
Timeline
QA Batch release Specialist
Novartis RLT, Indianapolis
03.2025 - Current
Quality Assurance Operations Specialist
AAA, a Novartis company (Millburn, NJ)
03.2024 - 03.2025
Quality Assurance senior specialist
LIPTIS PHARMACEUTICALS USA INC
01.2022 - 03.2024
API-Sales Specialist
MSN PHARMACEUTICALS INC
10.2019 - 12.2021
Pharmacy Technician
CVS SPECIALTY PHARMACY, NY
05.2019 - 10.2019
Pharmacy Technician
AMSTERDAM PHARMACY AND SURGICAL SUPPLIES, NY, NY
10.2016 - 12.2018
Pharmacy Technician
MISHKIN PHARMACY, NY, NY
07.2016 - 10.2016
Pharmacy Technician Intern
WALGREENS PHARMACY, EL DORADO HILLS, CA
02.2016 - 02.2016
Clinical Pharmacist Intern
M S RAMAIAH HOSPITALS, BENGALURU, KARNATAKA, INDIA
10.2014 - 10.2015
CALIFORNIA STATE UNIVERSITY
Pharmacy Technician Course from Pharmacy
M S RAMAIAH COLLEGE OF PHARMACY
Doctor of Pharmacy from Pharm D