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PPD

QA Auditor I (APAC)

Summarized Purpose:

The Clinical Quality Auditor Iassesses company activities to assure that contractual obligations to clientcompanies are met and determines whether clinical trials are conducted andreported in accordance with ICH Guidelines, regulatory requirements, andrelevant PPD and client procedural documents.

Implement the PPD Annual AuditProgram by performing routine investigator site audits, study file audits, andstudy document reviews (e.g., Informed consent, CRF, source documenttemplates), vendor audits, process audits and other audit types. Workassignments include multiple therapeutic indications across different projectsand clients. May also support client audits and inspection and other taskspertinent to the scope of the Audit Management team.

Essential Functions:
  • Conductsa variety of client, internal or GxP audits and supports regulatory inspectionsas requested by senior management
  • Participatesin process audits
  • Performsother types of QA audits or activities (e.g. database audits, clinical studyreport audits, sample results tables, facility audits, process improvement)
  • Servesas a resource to operational departments on audit or quality assurance subjectmatter
  • Preparesand presents audit findings and/or other related information at departmental,internal operations or client meetings


Job Qualification:

Qualifications:

Education and Experience:
  • Bachelor's degree in life science or allied medical courses (Nursing, Pharma, Biology, etc)
  • At least 5 years' previous CRA experience with exposure in quality audit and inspection that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.
  • 3 years' experience in conducting quality audit and inspection in a clinical trial/study setting.

Knowledge, Skills and Abilities:
  • Detailed knowledge of GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
  • Demonstrated ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH guidelines and to all other standards or guidelines applicable to business-related requirements
  • Demonstrated ability to independently review study documents for compliance with regulatory requirements or PPD procedures (e.g. Informed consents, protocols, CRFs, Source Document Templates, method validations, equipment qualifications)
  • Achieves acceptable standards of quality and meets timelines for QA deliverables and required departmental reports
  • Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
  • Very good problem solving, risk assessment and impact analysis abilities
  • Proficient at negotiation and conflict management
  • Flexible and able to multi-task and prioritize competing demands/work load
  • Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
  • Amenable to travel at 80% capacity with at least once a month international travel


Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

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