PRAHS

  • Quality Assurance Auditor

    Job Locations (All) | Singapore
    Posted Date 1 month ago(11/8/2018 6:19 AM)
    ID
    2018-49803
  • Overview

    Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

    Responsibilities

    You will work closely with internal PRA groups to 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.

     

    You will frequently interact with internal PRA groups consultating, mentoring and providing 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. You will also consult 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

    Qualifications

    • 5+ years experience working the clinical (GCP) QA function within a clinical pharmacology unit (preferred) or investigator/academic site
    • Clinical site auditing and process/procedural auditing against GxP regulations
    • Process improvement experience.
    • Experience working with/within a clinical research organization preferred
    • 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, auditing, etc. from an accredited institution or sufficient previous experience in auditing is preferred
    • Read, write and speak fluent English; fluent in host country language required
    • 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

    Your health, Your family, Your career — the things that matter to you, matter to us. The benefits of PRA just get better and better.

     

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

     

    For more information please visit our website: www.prahs.com

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