QA Auditor I (APAC) (TO-7EFC0)
Found in: Expertini
The Clinical Quality Auditor I assesses company activities to assure that contractual obligations to client companies are met and determines whether clinical trials are conducted and reported in accordance with ICH Guidelines, regulatory requirements, and relevant PPD and client procedural documents.
Implement the PPD Annual Audit Program by performing routine investigator site audits, study file audits, and study document reviews (e.g., Informed consent, CRF, source document templates), vendor audits, process audits and other audit types. Work assignments include multiple therapeutic indications across different projects and clients. May also support client audits and inspection and other tasks pertinent to the scope of the Audit Management team.
* Conducts a variety of client, internal or GxP audits and supports regulatory inspections as requested by senior management
* Participates in process audits
* Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
* Serves as a resource to operational departments on audit or quality assurance subject matter
* Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
_Education and Experience:_
* Bachelor's degree in life science or allied medical courses (Nursing, Pharma, Biology, etc)
* 1-2 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.
* Successful completion of PPD Foundation Training.
_Knowledge, Skills and Abilities:_
* Meets competencies for Associate QA Auditor plus:
* 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
**Job:** **Quality Assurance and Complian*
**Title:** *QA Auditor I (APAC)*
**Requisition ID:** *171772*
**Other Locations:** *TW-TW-Taipei, MY-MY-Kuala Lumpur*
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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