IQVIA
IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive
advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees
builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.
Job Title: QA Auditor
Job Description:
IMS Health and Quintiles have come together to be IQVIA. We have created a new way to harness advances in technology, analytics and human ingenuity called Human Data Science, to deliver solutions that help our customers drive healthcare forward and help patients around the globe. Inspired by the industry we help, our employees are committed to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.
PURPOSE
Plan, conduct, and report assigned quality assurance audits. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. Provide quality assurance oversight under the direction of senior QA staff through interaction with customers, project and study teams and associated Quintiles functions.
RESPONSIBILITIES
- Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Quintiles contracts to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.
- Conduct quality assurance activities and projects for clients according to Quintiles departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits.
- Assist in preparation and review of corrective action plans.
- Represent quality assurance program on customer and project teams under the direction of more senior QA staff.
- Document and report quality and compliance issues to QA management according to required timelines.
- Advise quality assurance management on system audit needs.
- Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed. May host some customer audits independently as directed by QA line management.
- Assist in preparation and review of corrective action plans associated with customer audits
- Enhance and maintain a working knowledge of relevant GXP regulations
- All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Knowledge of word-processing, spreadsheet, and database applications.
- Considerable knowledge of GXP regulations and quality assurance auditing techniques.
- Strong interpersonal skills.
- Excellent problem solving skills.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Qualifications:
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s/primary degree
- 3 years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
- Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
- Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
- Travel is required and may include some international travel.
