PRAHS

2017-41172

- | US-Remote
1 week ago
Title
Quality Assurance Auditor

Overview

Assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to. internal process audits, pharmacovigilance system audits, study specific audits (e.g.  investigator site, in process, pharmacy/distribution, trial master file), country office audits and audits of vendors used to support PRAHS services. 
Provides consultation, mentoring and compliance for the organization on GxP areas (e.g. GCP, GLP, GMP, GPvP, GDP, etc.) by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures (SOPs), company guidelines, and applicable regulations. Consults with PRA staff for interpretation of regulations.
May have responsibility to support specific operations such as:
  • Clinical Pharmacology Unit
  • Bioanalytical Laboratory
  • Logistics
  • GMP Pharmacy
  • Computerized Systems

Responsibilities

The auditor conducts the following activities with minimal supervision of QA management and/or more experienced auditor. As a result the auditor may conduct audits independently without the supervisor being physically present at the audit.
  • Performs contracted, routine and complex internal audits according to client expectations and/or PRA SOPs. May function as a lead auditor on an audit team.
    • Plans and ensures audits are scheduled.
    • Conducts audits to identify non-conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness.
    • Reports non-conformities according to client or PRA SOPs and report templates.
    • Tracks, collects and reports responses and corrective actions per contract with client or PRA SOPs.
    • Documents closure of audits.
  • Interprets regulations and guidance documents governing GxP and applies the interpretation for the PRAHS staff.
    • Researches the published information, interacts with other QA/regulatory professionals and maintains knowledge of current expectations and new trends and proposed changes to regulations.
    • Shares questions and issues posed to QA with global PRA QA staff as necessary to insure best advice is obtained.
    • Compiles response from QA staff and literature and replies to customer and more broadly throughout PRA as needed.
  • Facilitates client audits and regulatory inspections of PRA to ensure that client auditors and inspectors receive access to needed documentation and staff with minimal disruption of ongoing operations.
  • May be assigned to participate in QA projects such as management of issue escalations, CAPA projects, or other QA initiatives with supervision.

Qualifications

  • Read, write and speak fluent English; fluent in host country language required.
  • 2+ years experience working the clinical, regulatory, or quality environment within CRO/ pharmaceutical / healthcare environment.
  • Excellent verbal and written communication skills, interpersonal skills.
  • Excellent organizational skills.
  • Must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas.
  • An undergraduate degree, its international equivalent in health sciences, pharmacy, laboratory, clinical research, and/or auditing, etc. from an accredited institution or sufficient previous experience in auditing is required. 
  • Experience working within a clinical research organization.
  • Experience in Quality Assurance function is strongly preferred.
  • Clinical site monitoring, GxP quality assurance auditing, and GxP regulations.





PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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