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QA Auditor III

( Responsibilities )

Provide leadership and consulting regarding regulatory inspection preparation as well as support to internal PPD staff during investigator site, sponsor facility, and PPD facility inspections. Provide routine updates to senior management within PPD regarding inspection status and outcomes. Assist client/internal teams with regulatory authority inspection responses when requested. Assist client/internal teams in development of regulatory notification letters as needed.

• Serve as a primary contact for consulting to internal PPD staff on issues of GCP compliance as well as PPD procedural compliance. Participate in PPD improvement initiatives on behalf of PPD GQ&C as necessary.

• Review and provide comment on study documentation as needed, such as client site audit responses, site level CAPAs, training materials, PPD procedural documents, and client SOPs. Plan, conduct, report, and oversee resolution of directed audits in collaboration with other GQ&C staff and/or client QA personnel.

• Lead/manage investigation efforts, evaluate documentation/evidence, provide guidance, and work in collaboration with applicable department(s) and other GQ&C staff regarding potential scientific misconduct and significant non-compliance cases.

( MUST qualification )

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Previous QA including GCP site auditing experience that provides the knowledge, skills, and abilities to perform the job (at least 3 years) ) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

( Preferred Experience, knowledge, skills, and availabilities )

• Candidates with directed audit, pre-inspection audit and inspection support experience are preferred.

• Strong working knowledge of GCP and appropriate regional research regulations and guidelines

• Able to demonstrate proficiency and lead a range of project based or internal GxP audits and vendor audits to high standards required by management

• Excellent oral and written communication skills (English)

• Strong problem solving, risk assessment and impact analysis abilities

• Solid experience in root cause analysis

• Flexible and able to multi-task and prioritize competing demands/workload

• Conducts and/or leads a variety of client, internal or GCP audits and regulatory inspection support as requested by senior management

• Leads directed site audits and/or sub-contractor audits

• Provides GCP consultation and support to PPD project teams and external clients

• Serves as a resources 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

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