Priyanka Chamoli Email and Phone Number
Priyanka Chamoli personal email
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Priyanka has more than 17 years of experience in Quality Assurance for Clinical studies. She is currently leading a team of QA and CSV specialist to manage a variety of Quality Assurance activities in a small to mid size CRO based in Australia.In her role, she is responsible for reporting to Senior Management and the Board of Directors. She is responsible for company's Internal Audit Program, Vendor Qualification Program, Risk Management, Computer System Validation Program, QA Consultancy, Study Audits, Controlled Documents, Issue Management, Hosting Client and Regulatory Audits, CAPAs and Quality Issues.She is also responsible for the eQMS system as the system owner. She is the primary point of contact for all Quality Agreements and client QA queries. She has a rich experience of conducting Investigator's site audits in 5 continents and 10 different countries which include USA, Australia, China, Philippines, lndia, Thailand, Singapore, Japan, South Africa and Europe for major pharma companies around the globe.She has conducted more than 100 site audits along with CDM audits, vendor audits and Trial Master File (TMF) audits. She is responsible for looking after all the billable audit activities in Asia Pacific region and to conduct audits and provide support to clinical trials worldwide for her current organization. The audit activities typically include everything from planning, scheduling, conducting audits to reviewing and approving CAPA and till closure of the audit. She has worked on 2 electronic audit management databases.Her experience also included identifying training needs for the QA and clinical research department and providing trainings to them. Reviewing SOPs for multiple department and writing/ reviewing SOPs for QA department is also part of her professional experience.Priyanka is a IRCA certified ISO 9001:2008 QMS Lead Auditor and a member of Society of Quality Assurance (SQA), Research Quality Association (RQA) and ARCS Australia.
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Vice President Quality AssuranceAvance Clinical Aug 2023 - PresentFirle, South Australia, Au -
Director Quality AssuranceAvance Clinical Mar 2019 - Aug 2023Firle, South Australia, Au -
Panel Member, Arcs Clinical Monitoring Advisory PanelArcs Australia Oct 2016 - Present
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Manager - Clinical Quality AssuranceArcs Australia Aug 2015 - Aug 2023
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Senior Quality Assurance AuditorInc Research Apr 2013 - Jun 2015Raleigh, North Carolina, UsSchedules, conducts, and documents assigned audits of the Company’s projects andoperational processes in accordance with approved procedures, schedules, and formats.Specific audit areas will include, but are not limited to: a. Investigator Sites b. Trial Master and Project Management Files c. Project Databases (and their development) d. Data Management Activities and Files e. Safety Reporting f. Final Study Reports g. Staff Training Records h. Vendors- Hosts Sponsor audits and assists senior QA personnel in Regulatory Authorityinspections per Company’s policies and procedures.- Writes and issues audit reports in accordance with standard Company formats andtimelines, ensuring clear communication of audit findings to the relevant project teammembers and/or functional area management.- Reviews responses to audit findings for appropriateness and completeness. Follow up asappropriate to obtain audit response.- Maintains accurate and timely documentation of QA auditing activities.- Serves as a trainer and mentor to less experienced QA Auditors.- Serves as Lead Auditor on team-based audits and/or for project audits.- Manages assigned quality issues in accordance with Company requirements.- Provides consultancy on quality and regulatory related issues for QA functions.- Provides training on quality/regulatory area to Operations departments.- Writes, reviews or revises QA Standard Operating Procedures (SOPs) / Work Instructions(WIs) -
Asst. Manager - Quality AssurancePanacea Biotec Ltd Jul 2010 - Mar 2013• Planning, organizing and conducting Quality System projects within the company.• Reports to senior management (Head – Quality Assurance) about any non-compliance/ issues and responsible for preparing appropriate tools to handle them.• Providing resolutions and advice for any Non Conformance and ensuring implementation of appropriate resolution and Quality standards.• Guiding and supervising subordinates to achieve their targets.• Developing and implementing training plans and imparting trainings and certification process after successful training.• Implementing and monitoring quality expectations on an ongoing basis.• Controls and coordinates the disposition of Quality systems.
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Senior Executive - Quality AssurancePanacea Biotec Limited Apr 2008 - Jun 2010• Planning, organizing and conducting Quality System projects within the company.• Reports to senior management (Head – Quality Assurance) about any non-compliance/ issues and responsible for preparing appropriate tools to handle them.• Providing resolutions and advice for any Non Conformance and ensuring implementation of appropriate resolution and Quality standards.• Developing and implementing training plans and imparting trainings and certification process after successful training.• Implementing and monitoring quality expectations on an ongoing basis.• Controls and coordinates the disposition of Quality systems.
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Research Associate - Quality AssurancePanacea Biotec Ltd Jun 2006 - Mar 2008• Assisting in planning, organizing and conducting Quality System projects within the company.• Assisting in preparation of resolutions and advice for any Non Conformance and ensuring implementation of appropriate resolution and Quality standards.• Developing and implementing training plans and assisting in imparting trainings and certification process after successful training.• Implementing and monitoring quality expectations on an ongoing basis.• Controls and coordinates the disposition of Quality systems.
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TraineePanacea Biotec Ltd Dec 2005 - May 2006
Priyanka Chamoli Skills
Priyanka Chamoli Education Details
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Icri (Dr. M.G.R. University, Chennai)Clinical Research -
Kendriya VidyalayaClass 12Th
Frequently Asked Questions about Priyanka Chamoli
What company does Priyanka Chamoli work for?
Priyanka Chamoli works for Avance Clinical
What is Priyanka Chamoli's role at the current company?
Priyanka Chamoli's current role is Vice President Quality Assurance at Avance Clinical.
What is Priyanka Chamoli's email address?
Priyanka Chamoli's email address is ch****@****ail.com
What schools did Priyanka Chamoli attend?
Priyanka Chamoli attended Icri (Dr. M.g.r. University, Chennai), Kendriya Vidyalaya.
What skills is Priyanka Chamoli known for?
Priyanka Chamoli has skills like Clinical Trials, Quality Assurance, Sop, Ich Gcp, Gcp, Cro, Pharmaceutical Industry, Clinical Research, Quality System, Capa, Regulatory Affairs, Clinical Development.
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