Teva Pharmaceuticals USA, Inc.

Quality Records Reviewer

Location US-FL-Davie
Requisition #
18-20773
# Positions
1
Experience (Years)
2
Category
Quality - Compliance

Overview

Under general supervision, conducts final audit of Batch Manufacturing Records (BMRs) and Packaging Records (PPRs). Referencing SOPs and checklists, assures that the records comply with company regulations and cGMPs.

Responsibilities

Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.

 

  • Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
  • Performs audits of BMRs and PPRs, which may include interacting with other departments for corrections and investigations.
  • Collects and assembles all documentation pertinent to that batch and prepares the package for review by department management for release.
  • Initiates and completes Quality Auditings’ computer data input for BMRs, PPRs and Laboratory Services Reports.
  • Assists in verification of BMR generation.
  • Ensures compliance with all Company policies and procedures, including safety rules and regulations.
  • Performs related duties as assigned.

 

Required Knowledge and Skills:

Knowledge of:

 

  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
  • Principles of auditing and performance evaluations
  • Principles of mathematical and statistical computations.
  • Business, scientific and personal computer hardware and software applications.
  • Business English usage, spelling, grammar and punctuation.
  • Pharmaceutical principles, practices and their applications.
  • Current Company policies, practices and procedures, including safety rules and regulations.

Qualifications

Skill in:

 

  • Observing, analyzing and troubleshooting problems, identifying alternative solutions, projecting consequences of proposed actions and implementing methods, procedures and/or techniques for resolution to support Company goals.
  • Responding to inquiries from management, employees and regulatory agencies.
  • Communicating clearly and concisely, both orally and in writing.
  • Operating scientific, business and personal computers.
  • Interpreting and applying Federal, state and local policies, procedures and regulations.
  • Establishing and maintaining cooperative working relationships with others.
  • Ensuring compliance with all Company policies and procedures, including safety rules and regulations.

 

Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and occasional business travel. Work is performed in an office environment.

 

Minimum Qualifications: High School diploma or equivalent, plus two (2) to four (4) years quality assurance experience; or equivalent combination of education and experience.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.