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PPD

Quality Review Specialist

Essential Functions:

  • Reviews documentation prior to client/regulatory audits to ensure documentation is complete. The position will coordinate IT participation and/or provide IT Overviews in company audits, coordinate/provide IT responses and coordinate responses and follow-up actions related to applicable audit findings
  • Ensures computer validation activities and company’s use of electronic records are following internal procedures, policies, and applicable international guidelines and regulations.
  • Develops project, program and/or company-level risk analysis plans
  • Provides input into various initiatives and participates in process/quality improvement projects
  • Ensures timelines are maintained with respect to IT compliance activities (e.g., client audits, CAPA and/or procedural documents).
  • Performs special projects, assignments, and administrative tasks per business needs.

Job Complexity
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

 

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).
Knowledge, Skills, Abilities:

 

  • Computer System Lifecycle Management/Software Development LifeCycle experience
  • Audits/assessment experience
  • Working knowledge of project management standards and practices
  • Basic consultancy skills
  • Good computer skills and proficiency with Microsoft Word, Excel, email software, virtual training delivery platforms, and various process improvement or learning design and development software
  • Extensive ability to query, compile, enter, track and maintain data and records management systems
  • Fundamental ability to translate issues into actionable business solutions
  • Close attention to detail to deliver concise and accurate requirements-based reports and deliverables
  • Effective ability to deliver products, services, and solutions in a collaborative and cross functional global environment, with an understanding of the user perspective
  • Effective oral presentation and written communication skills
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)
 

 

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