Prathima Choudhary

Reviewed the Master production record for manufacturing of commercial batches. Reviewed the master packaging batch records for commercial batches. Reviewed the production and packaging batch records for validation, stability, validation and submission batches.

Reviewed the sop's according to regulatory requirements. Follow the current version and trained updated SOPs before the due date. Monitored and ensured all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications.

Monitored and ensured all phases of drug manufacturing are in compliance with established specifications. Received, inspected, released and control of labels and outserts. Ensured quality compliance before, during and after each packaging run.

Involved in Sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Prepared of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspected and tested of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications.

Maintained detailed records of sampling, inspections and testing activities. Assigned and verified of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. Collected the packaged product samples for annual stability.

Performed room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. Conducted in process testing per manufacturing and packaging batch record instructions. Prepared controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures.

Maintenance of standard weights to perform daily verification of balances. Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards.

Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room. Filled out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork. Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.

Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and co

Operation Specialist - Quantum Technologies Inc - Remote

(2021-04 - 2021-08)

Client: IQVIA

• Responsible for the collection, data entry, routing, follow-up and timely reporting/submission of safety information in compliance with FDA regulations.
• Triaged every report to confirm the validity of the case and decide on the timelines in accordance with the regulatory requirements for submission and company specific standard operating procedures.
• Reviewed adverse event information received for completeness and consistency, initiates case follow-up activities/AE query management and independently generates narratives in accordance with department processes.
• Well versed with data entry and Quality Review of case reports in ARGUS.
• Thorough understanding of CFR, ICH, GCP, FDA guidelines and industry standards. Knowledge of database management and use of coding dictionaries (MedDRA and WHODD).
• Ensure protocol compliance with monitoring of specific study requirements.
• Follow established guidelines and ensure prompt and appropriate documentation of serious adverse drug reactions reported to sponsors or regulatory agencies.
• Expert knowledge of regulatory guidelines for adverse event reporting, maintaining current knowledge of FDA and EMEA regulations (European guidance), ICH/GCP guidelines and company SOPs.
• Ensuring regulatory timelines regarding adverse events reporting are met.
• Develop SOPs for Pharmacovigilance/Drug Safety department
• Adherence to company templates and guidelines for documentation and communications. Performed quality control activities to ensure complete and accurate case information has been entered into the drug safety database.
• Preparation of case narratives, in accordance to CIOMS, particularizing information that is medically relevant to the adverse events reported.
• Handled Clinical SAE, Spontaneous reports with their Quality review.
• Assessed reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.
• Followed company processes and guidelines for case management and closure activities.
• Data entry and Quality Review of case reports in ARGUS.
• Triaged every report to confirm the validity of the case and decide on the timelines in accordance with the regulatory requirements for submission
• Goal oriented, self-motivated with attention to detail and leadership ability.
• Ability to work well both independently and in team environment.
• Proactive approach to meeting objectives.
• Expert knowledge of regulatory guidelines for adverse event reporting, maintaining current knowledge of FDA and EMEA regulations (European guidance), company SOPs. Thorough understanding of 21 CFR Part 11, Knowledge of Argus database management

QA Inspector - Amneal Pharmaceuticals - Piscataway, NJ

(2018-04 - 2018-12)

• Monitored and ensured all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications.
• Monitored and ensured all phases of drug manufacturing are in compliance with established specifications. Received, inspected, released and control of labels and outserts. Ensured quality compliance before, during and after each packaging run.
• Involved in Sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures.
• Prepared of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab.
• Inspected and tested of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications.
• Maintained detailed records of sampling, inspections and testing activities.
• Assigned and verified of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA.
• Collected the packaged product samples for annual stability.
• Performed room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures.
• Conducted in process testing per manufacturing and packaging batch record instructions.
• Prepared controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintenance of standard weights to perform daily verification of balances.
• Labeling component receipt, visual examination, counting, preliminary inspection and sampling.
• Preparation of labeling components/outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards.
• Issuance of labeling components/outserts according to packaging order and regular monitoring and auditing of label room.
• Filled out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork.
• Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions.
• Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)
• Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step
• Verification of functionality of all the equipment and associated controls during the batch run
• Maintenance of retention sample room and monitoring of temperature and humidity, replacement of chart records as per schedule, review of log and disposition of samples.

QA Analyst in Quality Assurance department - KOCH Organics - India

(2013-03 - 2014-04)