This site uses cookies. To find out more, see our Cookies Policy

Sr QA Auditor (R1077246) in Buenos Aires, Argentina at IQVIA™

Date Posted: 6/2/2019

Job Snapshot

Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

JOB DESCRIPTION

PURPOSE

Provide support to mgmt in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage QA oversight of projects, assignments, and training. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

RESPONSIBILITIES

 Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions.

 Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.

 Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.

 Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.

 Prepare, review and approve corrective action plans

 Present educational programs and provide guidance to operational staff on compliance procedures.

 Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.

 Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

 Host customer audits

 Host mock regulatory inspections and regulatory facility inspections

 Provide training for new Quality Assurance staff.

 Serve as author of Quality Assurance SOPs as assigned.

 Advise Quality Assurance management on system audit needs.

 Act as regional or Global QA Coordinator for assigned customers projects

 Oversee documentation, reporting, and closure of compliance issues

 Lead Projects.

 Train new auditors and staff as required.
    To supervise the performance of Latin America affiliate laboratories, working closely with Technical Services department.

    To manage regional non-conformities

    To conduct Vendor and Internal Audits

   To host sponsor audit and regulatory inspections

   To provide general QA support for Latin America operational departments

   To provide QA global support to another regions as needed.

   To lead the medium-term archive team.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

 Knowledge of word-processing, spreadsheet, and database applications.

 Extensive knowledge of pharmaceutical research and development processes and regulatory environments.

     Considerable knowledge of quality assurance processes and procedures.

 Strong interpersonal skills.

 Excellent problem solving, risk analysis and negotiation skills.

 Exceptional training capabilities.

 Effective organization, communication, team orientation, and leadership skills.

 Ability to work independently with initiative.

 Ability to manage multiple projects.

 Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

 Bachelor’s/primary degree

 7 years Quality Assurance experience in pharmaceutical, technical, or related area; 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.

 Occasional travel.



Job ID: R1077246

CHECK OUT OUR SIMILAR JOBS

  1. Auditor Jobs
  2. Internal Auditor Jobs