Priyanka Chamoli Email & Phone Number

Adelaide, Sa, Au

Firle, South Australia, Au

Firle, South Australia, Au

Raleigh, North Carolina, Us

Schedules, 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)

• 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.

• 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.

• 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.

M.Sc., Clinical Research

Class 12Th