VISHAL J. RAVAL

Email- ad4ixj@r.postjobfree.com Phone- 732-***-****

Summary: A dedicated and hardworking professional with 9+ years of experience in the pharmaceutical industry in batch record review, change control, CAPA, deviation, Investigation, SOPs. Looking out for a position to work in the Pharmaceutical/Medical Device industry in Quality Assurance Division.

Education –

Bechelor of Pharmacy- Rajiv Gandhi University, India. Completed in 2009

Master of Pharmacy in (Pharmaceutics) - Gujarat Technological University, India. Completed in 2012

MSCIS- American College of commerce and technology, Virginia, USA. Completed in 2015

Eugia Pharma

QA Reviewer (contract) Oct 2022 to Jan 2024

Responsible for the review of executed batch records in accordance with Eugia policies, SOP and cGMP.

Work closely with processes, including, deviations and investigations

Responsible for opening and closure of Deviation and perform Deviation Assessment as required.

Follows established procedures and performs work as assigned.

Work closely with cross functional teams to align and promote awareness on data integrity and good documentation practices

Provide Oversight to QA shop floor program. Review quality documents such as change control, IQ/OQ/PQ, SOPs, deviations, certificate of analysis, Batch Record and manage stability testing.

investigate OOS/OOT, deviations.

Assist completion of required documents corrections by interacting with responsible personnel on proper cGMP documentation practices.

Initiate deviation reports and participate in activities for issue resolution and CAPAs.

Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to implement corrective actions.

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Bristol Myers Squibb

Batch Record Reviewer (Contract) Jun 2022 to Oct 2022

Responsible for the review of executed batch records in accordance with BMS policies, SOP and cGMP.

Work closely with processes, including, deviations and investigations

Responsible for opening and closure of Deviation and perform Deviation Assessment as required.

Follows established procedures and performs work as assigned.

Work closely with cross functional teams to align and promote awareness on data integrity and good documentation practices

Provide Oversight to QA shop floor program.

Quva Pharma,inc

Quality Investigator and Continuous Improvement Specialist Aug 2021 to Jun 2022

Independently author and resolve deviations to meet production and product release requirements

Communicating across multiple groups and levels to drive deviation closure

Identifying interdepartmental process improvements and working cross- functionally to-implement them

Utilizing advanced root cause analysis techniques and technical impact

analyses during the deviation investigation process

Managing multiple priorities either independently or as part of a team to meet key deadlines and communicate issues and progress across all levels of organization

Communicating (both written and verbal) progress and updates across multiple levels of the organization

Performing more complex deviation investigations

Participates in the training process and coaching of new team members and processes

Helps assist with metric reporting and workload to meet the teams priorities

AUROBINDO pharma USA

QA Reviewer- Sterile Manufacturing March 2020 to Aug 2021

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Supported quality site manager to ensure open change control impacting product release followed cGMP and company procedures.

Performs batch documentation review and product release through collection of batch documentation.

Ensure deviations/nonconformances are closed in master control prior to release of a batch.

Prepare and present quality report, data, and metrics of key performance indicators to management.

Participated in corrective and preventive action processes.

Supported and managed internal and external audits.

Perform QA investigation or other assigned investigations as required.

Revise and train individuals on the SOPs relating to the investigation process. Participates in the development and delivery of training /refresher courses in quality systems and or GMP regulations and requirements and consultation as necessary.

Identify and implements quality improvements projects.

Review quality documents such as change control, IQ/OQ/PQ, SOPs, deviations, certificate of analysis, Batch Record and manage stability testing.

investigate OOS/OOT, IRs, deviations.

Assist completion of required documents corrections by interacting with responsible personnel on proper cGMP documentation practices.

Initiate deviation reports and participate in activities for issue resolution and CAPAs.

Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to implement corrective actions.

US Pharma Lab, New Jersey March 2016 to 03/22/20

Quality Assurance Specialist III

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Promote the importance of high-quality levels and the importance of a continuous improvement culture in all core company activities, and actively communicates with the various areas to identify areas for improvement

Prepares SOPs, quality related reports, and change control documents when appropriate.

Reviews completed batch records and associated deviations for final product

release.

Follows-up periodically of ongoing deviations and change controls to assure timely closure of documentation.

Reviews executed protocols and other GMP related documentation.

Responsible for evaluation/approval of equipment cleaning.

Review qualification/validation protocols.

Provides support to QA team during Client audits/inspections.

Follow-up periodically on client audits action plans and client complaints

Participate in regular inspections of the operational areas to verify compliance with cGMPs (i.e., internal audits)

Identify deficiencies of the Quality System and pro-actively suggests/requests improvements.

Perform complaint investigations and facilitate escalation as needed.

Zydus Cadila

Aug 2012 to Jan 2014 Executive -Quality Assurance

Performs routine manufacturing batch production record review in support of product release in accordance with cGMPs, specifications and SOPs.

Support manufacturing operations and staff as needed to identify and address product quality and compliance issues as they arise.

Reviews documentation associated with production operations.

Review and audit production batch records to ensure adherence to SOPs and cGMP requirements.

Provide support to QA Batch Release to assist with batch record release and compliance issues.

Initiate deviation reports and participate in activities for issue resolution and CAPAs.

Participates in activities associated with event resolution and CAPAs with a focus

on organizing and attending cross-functional meetings to implement corrective actions.

Write, review and approve Standard Operating Procedures (SOPs), as needed.

Able to provide input based on knowledge and experience on quality systems and procedures and CGMP.

Author and review relevant SOPs, validation and other documents.

Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.

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Support operations to encourage a Quality Culture and ensure a safe working environment.

Scion Pharma Pvt. Ltd. Sep 2009 to Aug 2010 QA Chemist

Master Batch Record Control, distribution, and label verification.

Perform line clearance activities as required.

Perform internal documentation audits as assigned.

Materials management nonconformance disposition and release activity as applicable.

Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures.

Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.

Track and trend relevant quality metrics including environmental monitoring data.

Provide Quality Assurance related support to various departments.

Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.

Electronic Document Control activities as assigned.

Perform other tasks or projects as assigned by supervisor or manager.

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